Responsive and scheduled neurostimulation for epilepsy

1. Introduction

Version followed: US device labelling as the manufacturers and FDA publish it (NeuroPace RNS System brief statement DN 1014760 Rev 4 and FDA PMA P100026 summary; Medtronic DBS epilepsy indication and safety text; LivaNova VNS Therapy US safety information), NICE HealthTech guidance HTG550 (formerly IPG678) for the UK, and for the psychological role the ILAE Psychology Task Force recommendations (Michaelis et al., 2018), ILAE depression recommendations (Mula et al., 2022, and the ILAE 2020 consultation draft) and the ILAE functional/dissociative seizures task force label (Hingray et al., 2025). All regulatory statements checked October 2026.

What it is. Responsive and scheduled neurostimulation for epilepsy is not a psychotherapy. It is a group of implanted medical devices that epilepsy neurology, neurophysiology and neurosurgery teams select, implant and programme as an add-on (adjunctive) treatment for drug-resistant epilepsy. Three device families are in current use [source: NeuroPace safety page; FDA SSED P100026; Medtronic DBS indications page; LivaNova US safety information]:

• Responsive (closed-loop) neurostimulation, the NeuroPace RNS System. An implanted neurostimulator monitors the brain's electrical activity, is designed to detect patterns previously identified for that patient, and delivers stimulation intended to interrupt the pattern before a clinical seizure occurs. FDA's summary states it is not a seizure-detection (alarm) device [source: FDA SSED P100026].
• Scheduled (open-loop) deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT), Medtronic. Bilateral stimulation of the ANT, programmed by the treating clinician [source: Medtronic DBS indications page].
• Vagus nerve stimulation (VNS Therapy), LivaNova. Scheduled stimulation of the vagus nerve, with on-demand stimulation by swiping a magnet and, in some models, an automatic extra stimulation when the device detects a rapid rise in heart rate that may accompany a seizure ("AutoStim") [source: LivaNova AspireSR page; LivaNova US safety information].

Regulatory status (as of October 2026, per the sources named).

Who delivers it. Selection by a multidisciplinary epilepsy team including a neurologist, neurophysiologist and neurosurgeon, in epilepsy-specialist neurosurgery centres (NICE, for DBS) [source: NICE HTG550]; VNS prescribers should be experienced in epilepsy and familiar with the system [source: LivaNova US safety information]. The psychotherapist never selects, programmes, adjusts or troubleshoots a device.

How change happens, and where the psychotherapist fits. The device aims to reduce seizure frequency; it is labelled as adjunctive, not curative [source: labelling above; LivaNova: "not a cure"]. The psychotherapist works alongside the team on what the device does not treat: the common psychiatric comorbidity of epilepsy (depression, anxiety, suicidality), adjustment to living with an implant, informed decision-making, and early detection and passing on of mood, behaviour and cognitive changes that the labelling asks the team to monitor. The ILAE Psychology Task Force urges that psychological treatment be an "integral part of epilepsy care" [source: Michaelis et al., 2018]. Psychological treatments do not replace the device or antiseizure medicines, and the therapist does not treat the epilepsy itself.

2. Framework

The device pathway is run by the epilepsy team; the phases below map the psychotherapist's work onto it. Session counts are not specified in any device source; the numbers given are [synthesis]. The ILAE supports individual, group, home-based and telehealth formats (STRONG) [source: Michaelis et al., 2018].

Phase A. Referral and evaluation (team assesses candidacy).

• Team goals: confirm drug-resistant epilepsy, localise seizure onset (RNS: no more than two foci), weigh surgical risk [source: NeuroPace safety page; NICE HTG550].
• Therapist goals: baseline assessment of depression, anxiety, suicidality, psychosis history, cognition complaints, substance use and social supports; psychoeducation; begin or continue treatment of any comorbid disorder. The DBS labelling asks clinicians to assess depression before surgery and weigh it against expected benefit [source: Medtronic]. The RNS pivotal trial excluded people with active psychosis, severe depression or suicidal ideation in the preceding year (a trial criterion, not a labelled contraindication) [source: FDA SSED P100026].
• Typical: 2–4 sessions, or folded into ongoing therapy [synthesis].
• Move on when: the team has made its candidacy decision and your assessment has been shared with consent [synthesis].

Phase B. Decision and consent.

• Goals: help the client understand what they have been told, including uncertainties, and reach a decision that fits their values. NICE requires clear written information on safety, efficacy and remaining uncertainties to support shared decision-making [source: NICE HTG550].
• Typical: 1–3 focused sessions [synthesis].
• Move on when: the client has decided (including deciding against) and can state the main benefits, risks and practical demands in their own words [synthesis].

Phase C. Implantation and early postoperative period.

• Team: surgery; surgical risks include infection, bleeding, tissue damage, pain and CSF leak [source: NeuroPace safety page]. In the RNS trial one serious "depression suicidal" event occurred in the postoperative period and resolved [source: FDA SSED].
• Therapist: closer contact (for example a check-in within the first weeks) focused on mood, sleep, pain-related distress and suicidality [synthesis].

Phase D. Programming and optimisation (months).

• Team: adjusts detection and stimulation; for DBS the labelling warns that starting, stopping or changing stimulation may increase seizures, cause new seizure types or status epilepticus, and asks for monitoring of mood, confusion and seizures when stimulation is adjusted [source: Medtronic]. Early benefit may be limited [synthesis].
• Therapist: monitor and pass on mood or cognitive change; work on expectations, frustration and device-related anxiety; continue comorbidity treatment.
• Move on when: the team describes the device as on a stable plan; for the therapist, when monitoring can return to routine frequency [synthesis].

Phase E. Long-term living with the device.

• Practical demands: RNS patients collect data from the device daily and send it weekly [source: NeuroPace safety page]; magnet use as the team instructs; MRI only under the manufacturer's conditions; avoidance of diathermy; possible further surgery for battery or hardware problems [source: NeuroPace; Medtronic; LivaNova].
• Therapist: standard psychological treatment for comorbid conditions; periodic re-screening; relapse prevention; driving, work and identity themes.

Phase F. Change or end (battery replacement, revision, removal, or non-response).

• Therapist: support grief or disappointment, decision-making about next options as the team presents them, and renewed safety monitoring at each transition [synthesis].

3. Guiding principles

• Stay in your lane on the device. Never comment on, suggest or troubleshoot settings, magnet use beyond what the team taught, or whether to keep, switch off or remove a device; route every such question to the team. Practical meaning: "That's one for your epilepsy team; let's write it down for them" [synthesis].
• Never imply a change in antiseizure medicines. FDA's 2008 advice to patients was "Do not stop taking these medicines without first talking with your healthcare professional" [source: FDA 2008 overview]. Practical meaning: ambivalence about medicines is explored, then taken to the prescriber.
• Psychiatric comorbidity is expected and treatable. Psychological care is integral to epilepsy care [source: Michaelis et al., 2018]. Practical meaning: screen actively rather than wait for disclosure.
• Suicide risk is raised in epilepsy. The ILAE draft notes suicide is more common in epilepsy than in the general population and that suicidal patients need urgent psychiatric review and close surveillance [source: ILAE 2020 draft]. DBS labelling reports depression, suicidal ideation and suicide in epilepsy patients, without an established causal link [source: Medtronic]; two of eleven deaths in the RNS trials were suicides [source: FDA SSED]. Practical meaning: ask about suicidality at every phase transition.
• Every client gets psychoeducation. The ILAE rates psychoeducation for all patients as STRONG [source: Michaelis et al., 2018]. Practical meaning: check understanding of epilepsy, the device and comorbidity early.
• Consent is a process, including the uncertainties. NICE explicitly requires uncertainties to be explained [source: NICE HTG550]; RNS labelling states long-term effects of brain stimulation are not completely known [source: NeuroPace safety page]. Practical meaning: help the client hear the uncertainty, not only the hope.
• The device is adjunctive and not a cure. Practical meaning: frame goals as fewer or less disabling seizures alongside continued medicines and safety precautions; VNS labelling advises consulting a physician before unsupervised activities such as driving, swimming or bathing [source: LivaNova].
• Know the contraindications that touch mental-health care. ECT, TMS and diathermy are contraindicated with RNS [source: NeuroPace]; diathermy and TMS are contraindicated with DBS and ECT safety is not established [source: Medtronic]; diathermy is contraindicated with VNS [source: LivaNova]. Practical meaning: if psychiatry considers brain stimulation for depression, make sure the treating teams know the implant exists.
• Pass on, don't interpret. Changes in mood, behaviour, memory, confusion or new event types are reported to the team for assessment, not attributed by the therapist to the device, medicines or psychology [synthesis, based on labelling monitoring duties].
• Name functional/dissociative seizures carefully. Diagnosis is a specialist task; use the ILAE-proposed term "functional/dissociative seizures" when the team has made that diagnosis [source: Hingray et al., 2025; ILAE FDS page].
• Consent-based information sharing. Agree at the outset what you will share with the team and when you would share without delay (risk to life) [synthesis].
• Involve carers where the client wishes. RNS is contraindicated for people who cannot operate the remote monitor or magnet or lack help to do so [source: NeuroPace], so carers are often part of the system. Practical meaning: offer carer sessions and attend to carer strain.

4. Intervention inventory

Part A describes how the team delivers each device, at a descriptive level only, so you can follow what your client is going through. It contains no settings, parameters or programming details, which belong solely to the treating team. Part B gives the psychotherapist's own interventions.

Part A. How the treatment is delivered (descriptive)

A1. Responsive neurostimulation (NeuroPace RNS System)

• Purpose and when used: adjunctive treatment for adults with drug-resistant focal epilepsy arising from one or two localised areas, as in the indication above [source: NeuroPace safety page].
• What happens: after evaluation that localises seizure onset, a neurosurgeon implants a neurostimulator and leads; the device monitors brain electrical activity, detects patterns previously identified for the patient and responds with stimulation intended to interrupt them. The physician configures and can adjust detection for each patient [source: FDA SSED P100026]. At home the patient or carer uses a remote monitor to collect data from the device daily and send it weekly to a data management system the team reviews [source: NeuroPace safety page; FDA SSED]. A magnet held over the device suppresses therapy while in place and, if programmed, triggers storage of a recording [source: FDA SSED]. Use the magnet only as the team has taught; never advise on it.
• Contraindications: high surgical risk; other implanted devices delivering electrical energy to the brain; inability to operate the remote monitor or magnet without help; ECT, TMS and diathermy [source: NeuroPace safety page].
• Warnings relevant to daily life: electromagnetic interference (for example security screening, RFID) may cause injury or unwanted stimulation; MRI only under the manufacturer's conditions for the RNS-320 model, while the RNS-300M is labelled MR Unsafe; external components must never enter the MRI room; possible further surgery for battery or hardware problems; not studied in pregnancy; "The effects of long-term brain stimulation are not completely known" [source: NeuroPace safety page].
• Adverse events listed: serious events include infection, change in seizures, device removal, death, lead damage, antiseizure drug toxicity, haemorrhage, psychiatric events, status epilepticus and seizure-related injury [source: NeuroPace safety page]. In the pivotal trials non-serious depression was reported at similar rates in active and sham groups; one postoperative serious suicidal-depression event resolved; two of eleven deaths were suicides; seven deaths were attributed to possible, probable or definite SUDEP [source: FDA SSED]. FDA's summary reports no significant between-group difference in neuropsychological domains at the end of the blinded period [source: FDA SSED].
• Watch for (therapist): low mood, hopelessness or suicidality after surgery or during programming; anxiety about the data the device records; burden of daily data collection.

A2. Scheduled deep brain stimulation of the anterior thalamus (Medtronic DBS for epilepsy)

• Purpose and when used: adjunctive treatment for adults with drug-resistant focal-onset seizures as in the indication above [source: Medtronic DBS indications page]. In England, anterior thalamic DBS is used only with special arrangements for governance, consent and audit or research, with selection by a multidisciplinary epilepsy team in specialist centres [source: NICE HTG550].
• What happens: leads are implanted in both anterior thalamic nuclei and connected to an implanted stimulator, which the team programmes and reviews over follow-up visits [source: Medtronic; NICE HTG550].
• Labelled warnings with psychological relevance: depression, suicidal ideation and suicide have been reported, without an established causal relationship; clinicians should assess depression before surgery and monitor closely afterwards for new or changing depressive symptoms; memory impairment has been reported and patients should be monitored for it; when stimulation is adjusted, monitor for mood change, confusion, new or increased seizures and tingling; psychiatric and behavioural disorders, including psychosis and abnormal thinking, and cognitive impairment are listed adverse events; starting, stopping or changing stimulation may increase seizures or cause status epilepticus [source: Medtronic DBS indications page].
• Contraindications: diathermy; TMS. ECT safety has not been established [source: Medtronic].
• NICE safety outcomes: device failure and off-target stimulation were the key safety outcomes the committee considered [source: NICE HTG550].
• Watch for (therapist): new depressive symptoms, memory complaints, confusion or behaviour change, especially around programming visits.

A3. Vagus nerve stimulation (LivaNova VNS Therapy), scheduled with on-demand and heart-rate-responsive options

• Purpose and when used: adjunctive treatment for drug-resistant focal-onset seizures from age 4 [source: LivaNova US safety information].
• What happens: an implanted generator stimulates the vagus nerve in the neck on a schedule the team programmes; the labelling contraindicates it after bilateral or left cervical vagotomy [source: LivaNova US safety information]. Swiping the magnet delivers extra stimulation intended to stop or shorten a seizure; the magnet can also be used to stop stimulation (for example if malfunction causes painful stimulation, or, as the label suggests, while eating to reduce aspiration risk). Some models add AutoStim, which responds to rapid heart-rate rises [source: LivaNova AspireSR page; LivaNova US safety information].
• Common effects: hoarseness, cough, sore throat, tingling and shortness of breath, which generally occur during stimulation; infection is the most common procedural complication [source: LivaNova AspireSR page]. Warnings include worsening or new obstructive sleep apnoea, swallowing difficulty and aspiration, breathing problems in people with lung disease, cardiac rhythm effects at implantation, and damage if the patient manipulates the device through the skin ("Twiddler's syndrome") [source: LivaNova US safety information].
• Not a cure: the label advises consulting a physician before unsupervised activities that could cause harm, such as driving, swimming, bathing or strenuous sports [source: LivaNova US safety information].
• Watch for (therapist): voice change and its social impact; sleep disturbance (pass on possible sleep-apnoea symptoms such as loud snoring or daytime sleepiness [synthesis]); repetitive touching or manipulating of the device in anxious clients or children (pass on).

Part B. The psychotherapist's interventions

B1. Baseline psychological assessment and repeated screening

• Purpose and when to use: at referral, before surgery, after surgery and at each programming phase; gives the team the psychiatric baseline the DBS labelling asks for and tracks change [source: Medtronic; synthesis for timing].
• Steps: (1) Clinical interview covering depression, anxiety (including fear of seizures), suicidal thoughts and past attempts, psychosis, substance use, trauma, cognition complaints, sleep and supports [synthesis]. (2) Add brief validated measures; the epilepsy literature uses the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) and PHQ-9 as outcome measures [source: ILAE 2020 draft]; follow licensing terms and local protocol. The ILAE draft gives no screening frequency [source: ILAE 2020 draft]. (3) Repeat at agreed points: before surgery, early postoperative weeks, during programming, then at routine intervals [synthesis]. (4) With consent, send a short summary to the epilepsy team.
• Example language (illustrative): "Your team asked how your mood has been, because mood matters for how people do with these devices. Can we go through some questions together, including some about thoughts of death?"
• Watch for: scores rising across phases; discrepancy between self-report and carer report; cognitive difficulty affecting questionnaire validity.

B2. Psychoeducation: epilepsy, comorbidity and the device

• Purpose and when to use: for every client (ILAE STRONG), early and repeated; includes seizures, treatments, comorbidities and self-management, adapted to developmental level for children [source: Michaelis et al., 2018].
• Steps: (1) Ask what the client already knows and fears. (2) Explain that depression and anxiety are common in epilepsy and treatable, and that psychological treatment works alongside, not instead of, neurological care. (3) Using the team's own written information, go over the device's purpose in plain words (adjunctive, aims to reduce seizures, not a cure). (4) Name the practical demands: data collection or magnet use as instructed, MRI and diathermy restrictions, possible further surgery. (5) Teach-back: the client explains it in their own words. (6) Note gaps and questions for the team. [source: Michaelis et al., 2018; device labelling; steps are synthesis]
• Example language (illustrative): "In your own words, what is the device meant to do, and what will it ask of you day to day?"
• Watch for: magical expectations ("it will switch my seizures off"), catastrophic fears ("it will control my mind"); either goes to the team as a question to clarify.

B3. Supporting informed consent and shared decision-making

• Purpose and when to use: during the decision phase and before any further surgery; NICE requires clear written information on safety, efficacy and remaining uncertainties [source: NICE HTG550].
• Steps: (1) Ask the client to summarise what the team said, including benefits, risks and uncertainties. (2) Help clarify values: what matters most (fewer seizures, driving, work, avoiding surgery, cognitive concerns). (3) Help write a question list for the team, for example on expected benefit, surgical risks, daily demands, MRI, what happens if it does not help, long-term unknowns. (4) Identify pressures (family, desperation after years of seizures) and whether depression is narrowing perceived options. (5) If capacity seems impaired by acute psychiatric symptoms, tell the team; capacity is assessed by the treating team [synthesis]. (6) Respect any decision, including declining. [steps: synthesis]
• Example language (illustrative): "It sounds like part of you wants this very much and part of you is frightened. Shall we list both sides and the questions only your surgeon can answer?"
• Watch for: consent driven by hopelessness; inability to recall key risks; avoidance of the topic.

B4. Expectation and adjustment work

• Purpose and when to use: before and after implantation, and through programming, when frustration with gradual or partial benefit is common [synthesis].
• Steps: (1) Set personal, valued goals that do not depend only on seizure counts (activities, relationships). (2) Normalise the adjustment of living with an implant: scars, body image, awareness of the device, security screening. (3) Use problem solving for practical burdens (data routines, appointments). (4) Address identity shifts if seizures fall (new expectations about work or independence). [synthesis; problem-solving and social activation rated STRONG for depression by ILAE: Michaelis et al., 2018]
• Example language (illustrative): "While your team works on the device, what would you like to be doing more of, seizures or not?"
• Watch for: all-or-nothing appraisal of the device; withdrawal; overprotection by family.

B5. Monitoring and passing on mood, behaviour and cognitive changes

• Purpose and when to use: throughout; the DBS labelling asks for close postoperative monitoring of depression, monitoring for memory impairment, and monitoring for mood change and confusion when stimulation is adjusted [source: Medtronic]; RNS lists psychiatric events among adverse events [source: NeuroPace].
• Steps: (1) Agree with client and team, in writing, what you will report, to whom, how fast, and the out-of-hours route. (2) At each session briefly check mood, sleep, anxiety, irritability, suicidal thoughts, memory or confusion, unusual thoughts or perceptions, and any change in seizures or new kinds of events. (3) Note timing relative to surgery, programming visits and medicine changes (the client's report only; do not interpret cause). (4) Report the same day for new or worsening suicidality, psychotic symptoms, confusion, or sudden behaviour change; route routine changes to the next team contact. (5) Document what you passed on. [steps: synthesis; warning signs below from FDA]
• Warning signs to pass on: FDA's 2008 patient advice for antiseizure medicines lists talk of hurting oneself or ending one's life, preoccupation with death, new or worse depression, withdrawal from friends and family, giving away prized possessions, and unusual, rapid changes in mood or behaviour, and tells patients to contact a healthcare professional right away [source: FDA 2008 overview]. Clients with these devices usually also take antiseizure medicines, so these signs apply.
• Example language (illustrative): "You mentioned feeling flat since the last programming visit. I'd like to let your epilepsy nurse know today, as we agreed. Shall we call together?"
• Watch for: clients minimising symptoms for fear the device will be removed; carers noticing changes the client does not.

B6. Suicide risk assessment and crisis and safety planning

• Purpose and when to use: at baseline, after surgery, during programming, at disappointment points and whenever warning signs appear. Suicide is more frequent in epilepsy; the ILAE draft recommends urgent psychiatric review and close surveillance for suicidal patients, with admission considered and sometimes needed without consent [source: ILAE 2020 draft].
• Steps: (1) Ask directly about suicidal thoughts, intent, plans, preparations and past attempts, following your service's current risk-assessment standard. (2) Build a written safety plan: personal warning signs, coping steps, people and places for distraction, people to ask for help, professional and emergency contacts (include the epilepsy team and the out-of-hours crisis line). (3) Lethal-means counselling: medicines, including stockpiled antiseizure medicines, are a common concern; agree safe storage or holding by a trusted person, without the client changing their prescribed regimen. (4) For imminent risk, follow emergency procedures and inform the psychiatric and epilepsy teams. (5) Review the plan at each phase transition. [steps: synthesis following standard practice]
• Example language (illustrative): "Some people feel hopeless when a treatment they waited for hasn't worked yet. Have you had thoughts of ending your life?"
• Watch for: hopelessness after non-response; postoperative low mood; isolation; acute stressors such as losing a driving licence.

B7. Psychological treatment of comorbid depression

• Purpose and when to use: for depressive symptoms at any phase. The ILAE rates skill-based and behavioural interventions (behavioural or social activation, problem solving, social skills training) as STRONG for depression, individual or group [source: Michaelis et al., 2018]; CBT has the best evidence for mild to moderate depression in epilepsy, and psychotherapy should be considered first for mild depression [source: ILAE 2020 draft]; one RCT found an effect of mindfulness-based cognitive therapy [source: ILAE 2020 draft]; UPLIFT (distance-delivered MBCT) and PEARLS are named programmes [source: Michaelis et al., 2018].
• Steps: use the standard protocol you are trained in (behavioural activation, problem-solving therapy, CBT or MBCT), adapted for epilepsy: (1) build activity plans compatible with the team's safety advice (driving, swimming, heights); (2) include seizure- and device-related appraisals in cognitive work; (3) allow for fatigue and cognitive load (shorter sessions, written summaries); (4) refer to psychiatry for moderate to severe depression, psychotic depression (urgent) or suicidality (urgent) [source: ILAE 2020 draft; adaptations are synthesis]. Medicine decisions belong to the prescriber; the ILAE recommendations on antidepressants are for prescribers [source: Mula et al., 2022].
• Example language (illustrative): "Let's pick two activities this week that your team is happy with and that used to matter to you."
• Watch for: improvement on measures and in activity; no change after an adequate course means review with the team and psychiatry.

B8. Treating seizure-related and device-related anxiety

• Purpose and when to use: fear of seizures, of injury or of seizures in public; fear of surgery; health anxiety focused on the implant (checking, avoiding MRI, security screening, magnets). ILAE evidence for anxiety is limited; mindfulness-based interventions are rated WEAK [source: Michaelis et al., 2018]. Other techniques here are [synthesis] from general anxiety treatment.
• Steps: (1) Separate realistic precautions (those the team or labelling sets) from avoidance that goes beyond them; get the team's activity advice in writing. (2) Formulate the anxiety cycle (threat appraisal, safety behaviours, avoidance). (3) Use mindfulness-based or CBT approaches; for avoidance, graded exposure only to situations the team has cleared, with informed consent, a seizure plan in place, and no exposure that recreates real hazards (for example swimming alone). (4) Address hypervigilance to bodily sensations, distinguishing reporting of genuine new symptoms (always pass on) from checking. (5) Pre-surgical anxiety: preparation, relaxation and coping statements. [synthesis]
• Example language (illustrative): "Your team says the supermarket is fine with someone along. What would be a first step there?"
• Watch for: exposure steps that the team has not cleared; anxiety escalating into panic that the client or family mistake for seizures (report descriptions to the team, do not decide what an event was).

B9. Adherence and ambivalence conversations

• Purpose and when to use: when a client is ambivalent about antiseizure medicines, data collection, clinic visits or the device itself. Multicomponent education plus problem solving is rated STRONG for medication adherence [source: Michaelis et al., 2018].
• Steps: (1) Explore ambivalence with open questions and reflective listening. (2) Identify practical barriers (forgetting, routines, side effects) and problem-solve reminders and routines. (3) Any wish to stop, reduce, switch off or remove anything is taken to the prescriber or team; the therapist neither endorses nor opposes it. (4) Help the client prepare how to raise it. [synthesis]
• Example language (illustrative): "It makes sense you're tired of the daily routine. What would you want your team to know about that?"
• Watch for: covert non-adherence; abrupt stopping of medicines (FDA warns sudden stopping can cause serious problems) [source: FDA 2008 overview].

B10. Cognitive complaints

• Purpose and when to use: memory or concentration complaints, which the DBS labelling asks the team to monitor [source: Medtronic]. Mindfulness-based training is rated STRONG for neurocognitive complaints, and HOBSCOTCH (home-based cognitive-behavioural self-management) and ACT are named [source: Michaelis et al., 2018].
• Steps: (1) Pass on new or worse complaints to the team for assessment, including possible neuropsychological testing. (2) Offer compensatory strategies (diaries, phone reminders, routines) and stress reduction. (3) Treat co-occurring depression, which can worsen subjective cognition [synthesis].
• Example language (illustrative): "Let's note exactly what you're forgetting and since when, so your team has something concrete."
• Watch for: sudden change or confusion (report promptly).

B11. Distinguishing functional/dissociative seizures, as sources describe

• Purpose and when to use: when the team has diagnosed functional/dissociative seizures (FDS), or when the client or family describe events that differ from their usual seizures. The ILAE describes FDS as events that look like epileptic seizures but, in its patient-page description, are not caused by brain dysfunction, and as a mental health disorder, classed in DSM-5 as functional neurological symptom disorder with seizures and in ICD-11 as dissociative neurological symptom disorder with non-epileptic seizures, and needing multidisciplinary management [source: ILAE FDS page]. The ILAE task force proposes the term "functional/dissociative seizures" to replace "psychogenic nonepileptic seizures" [source: Hingray et al., 2025]. Diagnosis is made by specialists; the ILAE lists a staged approach to diagnosis (LaFrance et al., 2013) [uncertain]. That FDS can co-occur with epilepsy is widely described [uncertain].
• Steps: (1) Never label an event yourself; record the client's or witness's description and pass it to the team. (2) If the team diagnoses FDS, use the team's explanation and terminology consistently, and offer or refer for psychological treatment of FDS in a specialist pathway [synthesis]. (3) Help the client hold both diagnoses if both are present, without implying either is "not real" [synthesis]. (4) Keep the safety plan for epileptic seizures intact.
• Example language (illustrative): "Your team says some of your attacks are functional seizures. They are real and treatable, and different from your epileptic seizures. What did you make of what they told you?"
• Watch for: the client feeling disbelieved; family stopping seizure first aid for all events; stigma.

B12. Working with carers, parents and children

• Purpose and when to use: carers often operate the remote monitor or magnet (RNS is contraindicated without that capacity or help) [source: NeuroPace]; VNS is used from age 4 and the labelling asks that patients, parents and carers be warned against manipulating the device [source: LivaNova]. The ILAE rates interventions for social and family problems, including parenting, as STRONG, and advises adapting psychoeducation for children [source: Michaelis et al., 2018].
• Steps: (1) With consent, include carers in psychoeducation and safety planning. (2) Assess carer strain and mood; refer carers for their own support. (3) For children, use family-involved CBT approaches as the ILAE suggests where epilepsy-specific evidence is lacking [source: Michaelis et al., 2018]. (4) Address overprotection and the young person's autonomy. [steps 1, 2, 4: synthesis]
• Example language (illustrative): "You've become the expert on the device at home. How is that for you?"
• Watch for: carer burnout; conflict over independence; a child touching or worrying at the implant site (pass on).

B13. Coordinating with other medical and mental-health treatments

• Purpose and when to use: when psychiatry or other services consider treatments that interact with the implant. ECT, TMS and diathermy are contraindicated with RNS; TMS and diathermy are contraindicated with DBS and ECT safety is not established; diathermy is contraindicated with VNS; MRI is restricted to manufacturer conditions for all three [source: NeuroPace; Medtronic; LivaNova]. The ILAE draft notes rTMS safety and efficacy data in epilepsy are lacking [source: ILAE 2020 draft].
• Steps: (1) Keep the implant type and model, if known, in your records. (2) If depression treatment escalates to brain stimulation, check that the psychiatrist and the epilepsy team are both informed and talking. (3) Remind clients to tell every clinician (dentist, physiotherapist, radiology) about the implant and to carry the device card the team provides [synthesis]. (4) Do not suggest or oppose any treatment yourself.
• Example language (illustrative): "Before anyone plans magnetic or electrical treatments for your mood, they'll need to talk to your epilepsy team about your implant."
• Watch for: fragmented care across services.

B14. Integrating psychotherapy before, during and after, and support after treatment ends

• Purpose and when to use: across the whole pathway, and when the device is replaced, revised, removed or judged not to help [synthesis].
• Steps: (1) Before: assessment, psychoeducation, decision support, treatment of comorbidity. (2) During: closer monitoring after surgery and around programming, continuation of therapy. (3) After a stable phase: relapse prevention, valued living, routine re-screening. (4) At change or ending: process disappointment or grief, renew the safety plan, support decision-making about next options the team offers. (5) Close with a written plan covering warning signs, who to contact, and how to re-access psychological care. [synthesis]
• Example language (illustrative): "Whatever your team decides next, let's make sure you know who to call if your mood dips."
• Watch for: abrupt loss of contact after a device decision.

5. Handling problems

All responses below are [synthesis] unless a source is named.

• Disappointment or non-response during programming. Validate; revisit what the team said about expected time course and partial benefit; screen for hopelessness and suicidality (B6); encourage the client to raise it with the team; refocus on valued goals (B4).
• New low mood or suicidality after surgery or a programming change. Assess risk; same-day report to the epilepsy team and psychiatry as agreed; the DBS labelling requires close postoperative monitoring for depressive symptoms [source: Medtronic]. Do not speculate whether the device caused it.
• Client asks you to help adjust, switch off or "test" the device, or to use the magnet differently. Decline kindly, explain that only the team can advise, and help them contact the team. Note the DBS warning that stopping or changing stimulation may increase seizures [source: Medtronic].
• Client wants to stop antiseizure medicines because "the device does it now". Explore the hope and ambivalence; route to the prescriber; FDA advises not stopping without talking to the healthcare professional [source: FDA 2008 overview].
• Preoccupation with the device's data or with sensations near the implant. Formulate as health anxiety; reduce checking that is beyond the team's instructions while preserving prescribed routines (RNS daily data collection) [source: NeuroPace]; any genuinely new symptom is passed on.
• Resistance to psychological referral ("my problem is neurological"). Use the ILAE framing that psychological care is part of epilepsy care [source: Michaelis et al., 2018]; start with practical goals (sleep, coping with seizures, adherence) rather than diagnosis labels.
• Overwhelm from information and appointments. Simplify: one-page summaries, a shared calendar, carers present with consent; pace sessions to fatigue and cognitive load.
• Rupture over information sharing. Return to the written agreement on what is shared; explain urgent-sharing limits again; involve the client in every report where possible.
• Events that look different from usual seizures, or the team raises FDS. Do not decide what the events are; describe and pass on; if FDS is diagnosed, support acceptance and specialist psychological treatment (B11). Keep epileptic-seizure safety plans in place.
• A seizure during an in-person or video session. Follow the client's seizure plan and your service's first-aid and emergency procedure; for video sessions keep the client's location and an emergency contact on file. Do not touch the implant or use a magnet unless the client's written seizure plan names you or a carer for that purpose.
• Need for MRI or another procedure for an unrelated problem. Prompt the client to tell the referrer and the epilepsy team about the implant; MRI only under manufacturer conditions [source: NeuroPace; LivaNova].
• Pregnancy or plans for pregnancy. RNS has not been studied in pregnancy, and DBS and VNS safety in pregnancy has not been established [source: NeuroPace; Medtronic; LivaNova]; encourage early discussion with the team and support decision-making.
• Psychiatry considers ECT or TMS for severe depression. Make sure contraindications are known (B13); in severe or psychotic depression ensure urgent psychiatric involvement [source: ILAE 2020 draft].
• Stigma, driving loss and work problems. Use problem solving and social-skills work (ILAE STRONG for social and family problems) [source: Michaelis et al., 2018]; driving rules are set by law and the team, not the therapist.
• Non-adherence to therapy tasks. Shrink tasks, check cognitive barriers, use reminders and carers, and link tasks to the client's own goals.
• Carer exhaustion or conflict. Offer carer sessions or referral; renegotiate roles around the device and seizures.
• Therapist uncertainty or anxiety about the device. Ask the epilepsy team for the patient information they use; seek supervision; stay within psychological work.

Sources

Sources:

• NeuroPace RNS System safety summary (brief statement DN 1014760 Rev 4)
• FDA Summary of Safety and Effectiveness Data, RNS System, PMA P100026
• NeuroPace receives FDA guidance on PMA supplement for indication expansion into idiopathic generalized epilepsy (July 2026)
• NeuroPace Inc, Form 10-K for fiscal year 2025 (SEC EDGAR)
• Medtronic receives FDA approval for deep brain stimulation therapy for medically refractory epilepsy (Medtronic news release, 1 May 2018)
• Medtronic receives European CE Mark approval for deep brain stimulation therapy for refractory epilepsy (Medtronic news release, 16 September 2010)
• Medtronic: Deep brain stimulation indications, safety and warnings
• LivaNova VNS Therapy US safety information (HCP)
• FDA premarket approval database: VNS Therapy System, P970003
• LivaNova celebrates 25 years of vagus nerve stimulation therapy (LivaNova release, 11 July 2019)
• LivaNova AspireSR product page (HCP)
• NICE HTG550: Deep brain stimulation for refractory epilepsy in adults
• NICE HTG550 guidance PDF
• Michaelis et al. 2018, Psychological treatments for adults and children with epilepsy (ILAE PDF)
• ILAE draft: Treatment of depression in adults with epilepsy (October 2020)
• Mula et al. 2022, ILAE clinical practice recommendations for the medical treatment of depression in adults with epilepsy (Enlighten record)
• ILAE: Functional/dissociative seizures
• Hingray et al. 2025, Functional/dissociative seizures: proposal for a new diagnostic label and definition by the ILAE task force (White Rose record)
• FDA 2008 overview: antiepileptic drugs and suicidality (archived)

Papers cited:

• Michaelis R, Tang V, Goldstein LH, Reuber M, LaFrance WC Jr, Lundgren T, Modi AC, Wagner JL (2018). Psychological treatments for adults and children with epilepsy: evidence-based recommendations by the International League Against Epilepsy Psychology Task Force. Epilepsia 59:1282–1302.
• Mula M, Brodie MJ, de Toffol B, Guekht A, Hecimovic H, Kanemoto K, Kanner AM, Teixeira AL, Wilson SJ (2022). ILAE clinical practice recommendations for the medical treatment of depression in adults with epilepsy. Epilepsia 63(2):316–334.
• Hingray C, Popkirov S, Kozlowska K, et al., Reuber M (2025). Functional/dissociative seizures: proposal for a new diagnostic label and definition by the ILAE task force. Epilepsia 66(11):4162–4182.
• Minimum requirements for the diagnosis of psychogenic nonepileptic seizures: a staged approach. Epilepsia (2013) [uncertain: cited as listed on the ILAE page].

Referred to as [uncertain]: current EU (MDR) and UK regulatory status of ANT-DBS and VNS Therapy.