1. Introduction
Version followed: real-time fMRI neurofeedback (rtfMRI-nf) as reported in the founding pain study (deCharms et al., 2005, PNAS) and the later clinical research lines on amygdala training in depression (Young et al., 2017) and combat PTSD (Zotev et al., 2018), plus the EEG-fMRI "electrical fingerprint" approach (Keynan et al., 2019) and its FDA-cleared EEG descendant, Prism (K222101, 2023). Delivery is described at a general level only; no scanner, signal-processing or protocol settings are given.
Status: research only. Real-time fMRI neurofeedback is not an established or licensed clinical treatment for any mental-health or pain condition. It is offered in research studies with ethics approval, at imaging centres, by research teams (physicists, imaging staff, investigators, often psychiatrists or psychologists). A psychotherapist does not deliver it; the therapist's role is to recognise fit, refer to trials, prepare and support participants, and integrate psychotherapy around participation. The one related product with regulatory clearance, Prism, is an EEG (not fMRI) neurofeedback device and is described separately below. [source: Dudek & Dodell-Feder 2021; FDA 510(k) K222101 via Innolitics] [synthesis for role framing]
What it is. A participant lies in an MRI scanner while the activity of a chosen brain region (or a pattern across regions) is computed within seconds and shown back to them, typically as a moving bar or similar display, while they try mental strategies to move it up or down. In the 2005 study by Christopher deCharms (Omneuron, Menlo Park) with Stanford colleagues including Sean Mackey and John Gabrieli, healthy volunteers and people with chronic pain learned to change activation in the rostral anterior cingulate cortex, a region involved in pain perception; pain ratings tracked the direction of control. Strategies included shifting attention elsewhere in the body and re-appraising the pain as a neutral sensation. Control groups who received the same strategies without imaging, trained a region not involved in pain (posterior cingulate), or saw false (sham) feedback did not show the same gains. [source: deCharms et al. 2005 citation via Gabrieli lab and Stanford Mackey lab pages; study description via BPS Research Digest; Wikipedia: Christopher deCharms]
Core idea of change (as researchers state it). Brain circuits implicated in a symptom (pain processing, amygdala reactivity in depression and PTSD) can be brought under voluntary control through operant learning with immediate feedback; changing that activity or connectivity is hypothesised to shift symptoms, and learned control is tested in "transfer" runs without feedback. In depression, participants raised amygdala activity while recalling positive autobiographical memories; in PTSD veterans, they raised left amygdala activity during a happy-emotion induction task. The mechanism is not established, and part of the observed change may be non-specific (expectation, strategy practice, attention). [source: Young et al. 2017 abstract; Zotev et al. 2018 abstract; Dudek & Dodell-Feder 2021] [synthesis: the non-specific-effects point is an inference from sham-controlled designs and the meta-analytic caveats]
Where it sits now. deCharms later founded Brainful, a company working on fMRI-based self-observation tools; the sources cited give no information on later clinical trials or replication of the 2005 chronic-pain result [uncertain]. [source: Wikipedia: Christopher deCharms]
2. Framework
rtfMRI-nf has no treatment manual for clinical use. The framework below has two strands: (A) the stages research studies typically follow, and (B) the parallel stages of the psychotherapist's work. Session numbers and scan settings are deliberately not given; they vary by study and belong to the study protocol.
A. How studies run (descriptive) [source: Young et al. 2017; Zotev et al. 2018; Keynan et al. 2019; CRED-nf checklist, Ros et al. 2020]
- Recruitment and screening. Goal: enrol people who match the study's diagnostic criteria and can be scanned safely. Content: diagnostic interview and rating scales, medication status (some trials require participants to be unmedicated, e.g. Young et al. 2017), MRI safety screening, pregnancy rules, exclusion of conditions the protocol names. Move on: eligibility confirmed and written informed consent given.
- Baseline assessment. Goal: measure symptoms and any cognitive or behavioural targets before training (e.g. MADRS in depression; CAPS in PTSD; autobiographical memory recall). Move on: baseline complete; randomisation to experimental or control condition, usually blinded.
- Training visits in the scanner. Goal: learn to change the feedback signal. Format: a small number of scanner visits (studies vary); within each, blocks of trying to regulate with feedback alternate with rest or control blocks (e.g. counting backward). Participants may get a suggested strategy and report what they actually used. Move on: per protocol, not by clinical judgement.
- Transfer test. Goal: check whether control persists without the display. Format: runs in which the participant regulates without seeing feedback.
- Post-training and follow-up assessment. Goal: measure symptom and behavioural change with blinded raters where possible; collect safety, adverse-effect and acceptability data. Follow-up in the trials cited was short (e.g. one week in Young et al. 2017; authors called for longer follow-up).
- Study close and debrief. Goal: explain the study, possibly reveal group assignment (per protocol), communicate any incidental findings, and hand back to usual care.
B. Psychotherapist's parallel stages [synthesis]
- Before: stabilise, assess fit and risk, discuss the research option, support consent decisions, prepare for the scanner. Move on when the client has decided, with understanding, whether to enrol.
- During: brief check-ins around scanner visits, monitor mood, distress and safety, pass concerns to the study team (with consent), keep ongoing therapy steady and avoid adding new major interventions that could confuse study outcomes unless clinically needed (discuss with the study team).
- After: debrief, process the experience (including disappointment if no change or if assigned to a control condition), consolidate any useful strategies inside ordinary therapy, continue evidence-based treatment.
3. Guiding principles
- Research, not treatment. Always describe rtfMRI-nf as experimental; never present it as a cure or a substitute for established care. [source: Dudek & Dodell-Feder 2021] [synthesis for wording]
- Usual care continues. Participation should not displace evidence-based psychotherapy or medical care; ask the study team what concurrent treatment the protocol allows. [synthesis]
- The study team owns the procedure. You do not set targets, strategies or schedules; you support the person. Route all questions about the scan and protocol to the investigators. [synthesis]
- Free, informed, revocable consent. The client can decline or withdraw at any time without losing your care; your support must not feel like pressure. [synthesis; research-consent norms]
- Safety screening is the scanner team's job, but you can help it be accurate. MRI screening is only as good as the history given; encourage complete disclosure of implants, devices, fragments, patches and tattoos. [source: UPenn CAMRIS MRI risk clauses 2024]
- Respect blinding. Many trials use sham feedback; avoid speculating with the client about which arm they are in, and do not coach in ways the protocol has not agreed. [source: CRED-nf, Ros et al. 2020; Dudek & Dodell-Feder 2021] [synthesis for the therapist implication]
- Expectation management. Effects in controlled studies are modest and uncertain; help the client hold hope and realism together. [source: Dudek & Dodell-Feder 2021]
- Trauma- and distress-informed preparation. Emotion-provocation tasks, enclosed scanners and noise can trigger anxiety or trauma memories; plan grounding and exit options in advance. [source: UPenn CAMRIS 2024 for claustrophobia and anxiety] [synthesis for trauma planning]
- Confidentiality and data sharing only with consent. Share clinical information with the study team only with the client's written agreement. [synthesis]
- Watch commercial claims. Distinguish research rtfMRI-nf from cleared EEG products (Prism) and from unregulated "brain training" offers; attribute claims to their makers. [source: FDA 510(k) K222101 via Innolitics; MobiHealthNews 2023]
4. Intervention inventory
Part A describes how research teams deliver rtfMRI-nf and its EEG-fMRI variant, at a descriptive level, so you can explain it to clients. Part B is the psychotherapist's own work. No scanner, signal or protocol settings are given; these belong to each study's ethics-approved protocol.
A1. Regulatory and evidence status (what to tell clients)
- Purpose: give an accurate, current picture before any referral conversation.
- Content:
- rtfMRI-nf: research only; no regulatory approval as a treatment was identified [uncertain: not verified on regulator pages; NICE, EMA and MHRA positions not identified].
- Evidence: a meta-analysis of 17 controlled studies (410 participants, most commonly major depression) found participants could learn to regulate the target signal, a small effect on symptoms compared with controls (g = .37), likely smaller after correcting for publication bias (about g = .25), and no significant effect on cognition; the authors call for pre-registered, adequately powered trials and do not claim clinical readiness. [source: Dudek & Dodell-Feder 2021]
- Depression: in a double-blind randomised trial in 36 unmedicated adults, amygdala training during positive-memory recall produced larger reductions in depression ratings and more specific positive memories than training a control region; follow-up was one week and the authors call for larger samples, medicated patients and longer follow-up. [source: Young et al. 2017 abstract]
- PTSD: in combat veterans, amygdala upregulation training was compared with sham; the experimental group improved on CAPS, but the between-group difference in CAPS change was not significant. [source: Zotev et al. 2018 abstract via DOAJ]
- EEG-fMRI fingerprint: in 180 healthy people in stressful military training, amygdala-fingerprint EEG neurofeedback improved alexithymia and an emotional Stroop measure relative to controls. [source: Keynan et al. 2019 abstract via TAU/IUCC CRIS]
- Prism (GrayMatters Health): FDA 510(k) clearance K222101, 17 March 2023, Class II biofeedback device (21 CFR 882.5050), prescription use; cleared as EEG neurofeedback software for relaxation and stress reduction and as an adjunct to other treatments for PTSD symptoms, under the direction of a healthcare professional. The supporting study was single-arm and open-label. Age range given in a secondary summary (22–65) [uncertain: not verified in the FDA text]. As of October 2026 per the Innolitics 510(k) record; check current status. [source: FDA 510(k) K222101 via Innolitics; MobiHealthNews 2023]
- Certification: no practitioner certification for rtfMRI-nf was identified; general EEG neurofeedback certification (e.g. BCIA) does not qualify anyone to run MRI-based procedures [uncertain].
- Example language (illustrative): "This is an experimental method studied in research trials. Early results are interesting but small and not yet confirmed, so it would sit alongside our work, not replace it."
- Watch for: the client hearing "brain scan therapy" as a proven cure; promotional claims from companies; confusion between fMRI research and EEG clinic products.
A2. Screening and eligibility (study team)
- Purpose: studies select participants who fit the research question and can be scanned safely.
- What happens: structured diagnostic interview and rating scales; checks on current medication (some trials require participants to be unmedicated, others include medicated participants); MRI safety screening (A3); protocol-specific exclusions (e.g. excessive head motion led to exclusion in one trial). [source: Young et al. 2017; Dudek & Dodell-Feder 2021]
- Therapist relevance: a client may be asked to be medication-free for a trial. Never suggest stopping a medicine to qualify; any medication question goes to the prescriber and the study physician. [synthesis]
- Watch for: clients thinking about changing treatment to get into a study.
- Example language (illustrative): "The study may have rules about medication. If it does, that's a conversation for your prescriber and the study doctor, not something to change on your own." [synthesis]
A3. MRI safety screening (imaging centre)
- Purpose: prevent injury from the strong magnetic field.
- What happens (as research consent templates describe): a written screening form on implants, devices and foreign bodies; if an implant's risk cannot be judged, the scan does not go ahead. Rare but serious injuries can occur with metal implants, wearable sensors, medicinal patches, certain tattoos and hair weaves with metallic threads. Magnetic metal is removed from clothing and pockets; only approved staff bring objects into the magnet room. Earplugs are given because the scanner is loud; participants can still talk with staff. Possible effects include claustrophobia, anxiety, discomfort, nausea and tingling. Pregnant people are usually excluded from studies unrelated to pregnancy. Research scans are not clinical and are often not read by a radiologist, but unexpected (incidental) findings can arise and the investigator will say if action is needed. [source: UPenn CAMRIS MRI risk clauses, updated 12 Sept 2024]
- Therapist relevance: encourage full disclosure (past surgery, metal work exposure, shrapnel in veterans, implanted devices, patches, tattoos); flag claustrophobia and panic history so the team can plan. [synthesis]
- Example language (illustrative): "The safety form only works if it has the whole picture. Is there anything, even small or long ago, like metal fragments or a patch, that you weren't sure counted?"
- Watch for: shame or avoidance around disclosing history (e.g. injuries, body modifications); veterans unsure about retained fragments.
A4. Target definition (study team)
- Purpose: decide which brain signal is fed back.
- What happens: the protocol names a region or pattern (e.g. rostral anterior cingulate for pain; amygdala for depression and PTSD; a control region such as posterior cingulate or intraparietal sulcus for comparison groups). Some studies localise the region individually; the CRED-nf checklist asks studies to report whether the signal was individualised and how it was computed. [source: BPS Research Digest on deCharms 2005; Young et al. 2017; Ros et al. 2020]
- Therapist relevance: explains why the client may be told little about their target (blinding).
- Example language (illustrative): "They may not tell you exactly which brain area you're training. That's part of keeping the study fair, not a secret about you." [synthesis]
- Watch for: suspicion or distress about not being told the target; speculation that undermines blinding. [synthesis]
A5. Strategy instruction (study team)
- Purpose: give the participant a starting mental strategy.
- What happens: pain study: attending to another body part, or reappraising pain as a neutral sensation; depression: recalling positive autobiographical memories while trying to raise the bar; PTSD: a happy-emotion induction task. The CRED-nf checklist asks studies to report whether strategies were given and what participants actually used. [source: BPS Research Digest; Young et al. 2017; Zotev et al. 2018; Ros et al. 2020]
- Therapist relevance: if the team agrees, you can help the client prepare material in advance (e.g. identifying vivid, specific positive memories) [synthesis]. Do this only with the team's agreement, since pre-training may affect study results.
- Watch for: depressed clients who cannot access positive memories and feel they are "failing"; trauma clients whose "positive" memories are linked to lost comrades or people.
- Example language (illustrative): "The team will suggest a way of thinking to try in the scanner. Afterwards, tell them honestly what you actually did, even if it was different." [synthesis]
A6. Feedback training runs (study team)
- Purpose: learning control through immediate feedback.
- What happens: the participant watches a simple display of the target signal (e.g. a red bar to bring up to a blue target in the depression trial; live images in the pain study, with continuous pain ratings), alternating regulation blocks with rest or control tasks such as counting backward. [source: Young et al. 2017; BPS Research Digest; Wikipedia: Christopher deCharms]
- Therapist relevance: normalise the effort, frustration and fatigue these runs can bring. [synthesis]
- Example language (illustrative): "It's normal to find the bar hard to move at first, and to feel tired afterwards." [synthesis]
- Watch for: frustration, self-blame when the bar does not move, fatigue across repeated runs. [synthesis]
A7. Transfer runs and control conditions (study team)
- Purpose: test whether learning persists without feedback and whether effects exceed placebo.
- What happens: runs without the display; randomised comparison against sham feedback, feedback from an unrelated region, or no feedback, with double-blinding where possible and blinded outcome raters; adverse effects watched in both arms; a treatment-as-usual group is recommended for efficacy trials. [source: Ros et al. 2020; Dudek & Dodell-Feder 2021]
- Therapist relevance: prepare the client that they may be in a control group and may never know during the study.
- Example language (illustrative): "You might be in a comparison group and not find out until the end. Either way, your part in the study counts." [synthesis]
- Watch for: anger or loss of trust if the client later learns they had sham feedback. [synthesis]
A8. EEG-fMRI "electrical fingerprint" and Prism
- Purpose: move amygdala-targeted training out of the scanner.
- What happens: Keynan, Hendler and colleagues (Israel; record held on Israeli university research portals) used simultaneous EEG-fMRI to build an EEG model that tracks amygdala activity (amygdala electrical fingerprint, Amyg-EFP); trainees then do EEG neurofeedback, which can be delivered outside the imaging centre (in the trial, at a military base). Prism pairs an EEG cap with software using an amygdala-derived model, used by mental-health professionals in outpatient or private clinics, with patients practising self-directed strategies to lower their emotional response. [source: Keynan et al. 2019; MobiHealthNews 2023] Whether each Prism patient needs an individual fMRI scan is not clear in the sources cited [uncertain].
- Therapist relevance: Prism is a prescription, adjunctive device: it is used under the direction of a healthcare professional alongside other PTSD treatment. Training to deliver it comes from the manufacturer; no independent training route was found [uncertain].
- Watch for: marketing language (e.g. the company CEO's statement that it "augments standard of care") presented as evidence; the cleared indication is narrower than the marketing. [source: MobiHealthNews 2023; K222101]
- Example language (illustrative): "This EEG device is cleared only as an add-on for PTSD symptoms under a professional's direction; it doesn't replace your trauma therapy." [synthesis]
B1. Recognising when a research referral might fit
- Purpose: identify clients for whom a trial is a reasonable option. [synthesis throughout B unless stated]
- When: persistent depression, PTSD or chronic pain with partial response to established treatment, curiosity about neuroscience-based approaches, ability to tolerate scanning, stable enough to travel and engage.
- Steps: (1) check the client is receiving or has been offered evidence-based care; (2) ask about interest, not just eligibility; (3) screen informally for obvious MRI barriers (implants, severe claustrophobia, pregnancy) without making the decision yourself; (4) check current risk.
- Example language (illustrative): "Some research centres are testing whether people can learn to change activity in parts of the brain linked to mood. Would you want to hear more, knowing it's experimental?"
- Watch for: the client seeing the trial as a last hope; acute risk, which comes first.
B2. Finding and vetting trials
- Purpose: connect the client only with legitimate, ethics-approved studies.
- Steps: (1) search a public trial registry (e.g. ClinicalTrials.gov) with the client or for them; (2) check the sponsor is a university, hospital or recognised research centre with ethics approval and registration (pre-registration is a quality marker in the CRED-nf checklist [source: Ros et al. 2020]); (3) read the eligibility criteria together; (4) with consent, contact the study coordinator; (5) be wary of anyone charging fees for "fMRI neurofeedback therapy" outside a study.
- Example language (illustrative): "Let's look at the study listing together: who runs it, what they ask of you, and what happens if you want to stop."
- Watch for: paid, unregistered offers; travel or time demands that disrupt work, care duties or therapy.
B3. Psychoeducation about the method
- Purpose: an accurate mental model that reduces fear and inflated hope. [synthesis, drawing on facts in A1–A8]
- Steps: explain (1) what is measured: blood-flow-related activity, shown with a short delay, not thoughts; (2) that the scanner cannot read memories or private content; (3) the task: try strategies, watch a simple display, rate feelings; (4) possible sham or control conditions; (5) that research scans are not a health check, although incidental findings can occur [source for (5): UPenn CAMRIS 2024].
- Example language (illustrative): "The display shows roughly how active one brain area is, a few seconds behind. It can't see what you're remembering, only how hard that area is working."
- Watch for: fears of being "read"; paranoid or intrusive-thought content attaching to the scan; magical expectations.
B4. Supporting informed consent and shared decision-making
- Purpose: help the client make a free, informed choice; the consent itself is taken by the study team.
- Steps: (1) read the participant information together if the client wishes; (2) check understanding of: research purpose, randomisation and blinding, number and length of visits, MRI risks and screening, what happens to data and incidental findings, compensation, right to withdraw at any time without affecting their care; (3) list questions to ask the study team (e.g. Is concurrent therapy allowed? Who do I call if I feel worse? Will I learn my group?); (4) explore pros, cons and values; (5) respect the decision either way. Capacity concerns go to the study team and, where relevant, the treating psychiatrist.
- Example language (illustrative): "Whatever you decide, our work continues the same. What would make this worthwhile for you, and what would make you want to stop?"
- Watch for: deference to authority or to you; financial pressure from payments; consent given during a crisis.
B5. Preparing for the scanner
- Purpose: reduce avoidable distress and dropout.
- Steps: (1) assess claustrophobia, panic, noise sensitivity, trauma triggers (lying supine, enclosed space, restraint-like head padding, loud noise); (2) agree coping tools that do not require movement, since head motion can make data unusable and led to exclusion in one trial [source: Young et al. 2017]: paced breathing, grounding through body contact points, a planned focus image; (3) rehearse imagined scanner entry in session; (4) encourage the client to tell the team about anxiety and to learn the call or stop procedure the team provides; (5) plan the day: transport, a support person, a post-scan activity.
- Example language (illustrative): "If the space feels tight, notice the contact of your back on the table and lengthen your out-breath. And remember you can always tell the team you need to stop."
- Watch for: escalating anticipatory anxiety; plans to "push through" distress; using sedating substances without the prescriber's knowledge.
- Exposure note: brief imaginal rehearsal is a mild exposure; obtain consent, stop if distress escalates, and do not use it as formal claustrophobia treatment unless that is agreed and indicated.
B6. Strategy and memory work (only with the study team's agreement)
- Purpose: where a protocol uses autobiographical memory or emotion induction, help the client access suitable material safely.
- Steps: (1) ask the team whether preparatory work is permitted; (2) if so, help the client identify several specific, vivid positive memories, avoiding memories tied to loss or trauma; (3) practise brief recall and return to the present; (4) do not teach the client to aim for a particular brain region or tell them what the target is; (5) after visits, ask what they actually did, which the team may also ask (strategy reporting is a CRED-nf item [source: Ros et al. 2020]).
- Example language (illustrative): "Let's find a few memories where you felt at ease or proud, specific ones with a time and place, and check none of them carries a sting."
- Watch for: over-general memory and sadness in depression (specific positive recall was a study outcome [source: Young et al. 2017]); positive memories triggering grief or trauma.
B7. Safety and crisis planning around participation
- Purpose: keep risk management in place during an extra demand.
- Steps: (1) review the existing safety plan before enrolment; (2) agree how the client contacts the study team, you and crisis services if they feel worse after a visit; (3) with consent, agree with the study team who does what if suicidal thoughts or acute distress arise; (4) monitor suicidal ideation with your usual risk assessment at each check-in, especially if a trial requires being unmedicated (that decision is the prescriber's and study physician's).
- Example language (illustrative): "If you feel worse after a scan day, here's who you call first, and here's what we'll do."
- Watch for: worsening after medication-free periods; hopelessness when no improvement is felt.
B8. Monitoring and passing on adverse effects
- Purpose: studies are asked to collect adverse effects in all arms [source: Ros et al. 2020]; you may notice them first.
- Steps: (1) ask after each visit about headache, fatigue, nausea, dizziness, anxiety, sleep, mood, intrusive memories; (2) record and, with consent, report to the study team promptly; (3) urgent physical symptoms or acute risk go to emergency services or the treating doctor. Prism's supporting study reported mostly mild adverse events such as headache and fatigue [source: K222101 via Innolitics].
- Example language (illustrative): "Anything you've noticed since the scan, in your body, sleep or mood, is worth telling the team, even if it seems small."
- Watch for: minimising symptoms to stay in the study.
B9. Integrating psychotherapy before, during and after
- Purpose: keep therapy coherent and evidence-based around a research episode.
- Steps: (1) before: continue the current evidence-based treatment and ask the team whether therapy changes are restricted; (2) during: keep sessions steady, use them for preparation, processing and safety; avoid starting a major new treatment phase (e.g. intensive trauma exposure) at the same time unless clinically needed and discussed; (3) after: link any useful learning (e.g. that attention shifts or reappraisal changed pain, or that positive memories lifted mood) to ordinary therapy skills such as attentional control, reappraisal and positive memory rehearsal, without claiming brain change.
- Example language (illustrative): "You noticed that shifting attention changed how the pain felt. Let's practise that here, in everyday situations."
- Watch for: the client crediting or blaming the brain for everything, sidelining their own agency.
B10. Debrief and support after the study ends
- Purpose: close the episode well.
- Steps: (1) process the experience: what was hard, what was interesting; (2) if group assignment is revealed, help with disappointment or relief; (3) if an incidental finding was reported, support the client through follow-up with their doctor; (4) review symptom trajectory with your own measures; (5) decide next steps in therapy; (6) discuss interest in future studies.
- Example language (illustrative): "Whatever group you were in, you gave something to research and learned something about yourself. What do you want to carry forward?"
- Watch for: relapse after study support ends; anger if unblinding shows sham feedback.
B11. Conversations about commercial and off-trial offers
- Purpose: help clients evaluate claims.
- Steps: (1) ask what was offered and by whom; (2) check regulatory status against the regulator's own database (e.g. Prism's cleared indication is adjunctive PTSD treatment with EEG under professional direction, not fMRI therapy or a stand-alone cure [source: K222101]); (3) distinguish research participation from paid services; (4) encourage the client to discuss device-based treatments with their doctor.
- Example language (illustrative): "Let's check exactly what the regulator cleared it for, and what the evidence was, before you spend money."
- Watch for: high costs, guarantees, "rewire your brain" claims, discouragement from continuing standard care.
5. Handling problems
The research sources do not address therapist-side problems; everything below is [synthesis] unless a source is named.
- Client sees the trial as a last hope. Name the hope warmly, restate research status and modest effect sizes [source: Dudek & Dodell-Feder 2021], and agree a plan for what therapy will do whatever the outcome. Example (illustrative): "I want this to help, and I also want us ready if it doesn't."
- Ambivalence about enrolling. Use a decisional balance; separate curiosity from obligation; remind the client that declining has no effect on your care. Never persuade either way.
- Pressure to stop medication to qualify. Do not advise; route to the prescriber and the study physician; explore what the client hopes to gain and the risks they have been told about; increase monitoring if a medication-free period is agreed by the prescriber.
- Scanner anxiety or claustrophobia. Prepare as in B5; if the client still dreads it, support withdrawal as a legitimate choice. Claustrophobia and anxiety are listed MRI effects [source: UPenn CAMRIS 2024].
- Overwhelm during emotion tasks or trauma memories surfacing. Before: choose memories carefully (B6). After: grounding, containment, a check-in within a day or two, report to the study team, review the safety plan. If intrusions persist, address them in trauma-focused therapy once the client is stable.
- "I failed": no visible control or no symptom change. Normalise: not everyone learns to regulate the signal, the client may be in a control arm, and outcomes in this field are uncertain [source: Dudek & Dodell-Feder 2021; Ros et al. 2020]. Separate brain-signal performance from personal worth.
- Speculation about being in the sham group. Acknowledge the uncertainty; do not guess; note that wondering is normal; suggest asking the team at study close what they will share.
- Non-adherence (missed visits, dropping out). Explore barriers (travel, cost, fear, low mood); help the client contact the team; treat withdrawal as a right, not a failure; keep therapy continuous.
- Rupture: client feels you "sent them away" to a study. Repair directly: clarify that the referral was an option, not a handover; restate your ongoing role; invite their feelings about it.
- Rupture: you disagree with how the study team handles a concern. Raise it with the study team in writing (with consent); if a safety concern is not addressed, contact the investigator or the ethics committee named in the participant information.
- Incidental finding reported. Support the client in arranging follow-up with their doctor; address health anxiety; avoid interpreting the finding yourself [source for the possibility of incidental findings: UPenn CAMRIS 2024].
- Undisclosed metal or implant comes to light. Encourage immediate disclosure to the imaging team before any further scan; screening depends on accurate history [source: UPenn CAMRIS 2024].
- Paranoid or intrusive ideas about the scanner reading the mind. Psychoeducation (B3); if beliefs are fixed or distressing, discuss with the treating psychiatrist and the study team whether participation is appropriate.
- Client wants to buy commercial neurofeedback instead. Use B11; explain that Prism is cleared only as an adjunct for PTSD under professional direction [source: K222101]; other offers should be checked against regulator databases.
- Over-attributing change to the brain after the study. Credit the client's learning and effort; translate strategies into ordinary skills (B9).
- Relapse after the study ends. Plan in advance for the end of extra contact; schedule review sessions; resume or intensify evidence-based treatment.
Sources
Online sources:
- Control over brain activation and pain learned using real time functional MRI (Stanford Mackey lab publication page)
- Control over brain activation and pain learned using Real Time fMRI (MIT Gabrieli lab)
- Imaging the brain's control of the mind (BPS Research Digest)
- Christopher deCharms (Wikipedia)
- Randomized Clinical Trial of Real-Time fMRI Amygdala Neurofeedback for Major Depressive Disorder (American Journal of Psychiatry, abstract page)
- Real-time fMRI neurofeedback training of the amygdala activity with simultaneous EEG in veterans with combat-related PTSD (DOAJ record)
- Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience (TAU/IUCC CRIS)
- Dudek & Dodell-Feder 2021, rtfMRI-NF meta-analysis (author lab PDF)
- Consensus on the reporting and experimental design of neurofeedback studies (CRED-nf), University of Bristol record
- CRED-nf checklist full text (eScholarship)
- Prism, 510(k) K222101 (Innolitics FDA database record)
- GrayMatters Health receives FDA 510(k) for PTSD neuromodulation therapy (MobiHealthNews, 2023)
- MRI Risk Clause Language for Informed Consent Forms (UPenn CAMRIS, updated Sept 2024)
Articles cited (details as shown on the pages above):
- deCharms, C. R., Maeda, F., Glover, G. H., Ludlow, D., Pauly, J. M., Soneji, D., Gabrieli, J. D. E., & Mackey, S. C. (2005). Control over brain activation and pain learned by using real-time functional MRI. PNAS, 102(51), 18626–18631. (Full text not verified [uncertain].)
- Young, K. D., et al. (2017). Randomized clinical trial of real-time fMRI amygdala neurofeedback for major depressive disorder: effects on symptoms and autobiographical memory recall. American Journal of Psychiatry. [uncertain: authors and volume not verified]
- Zotev, V., Phillips, R., Misaki, M., Wong, C. K., Wurfel, B. E., Krueger, F., Feldner, M., & Bodurka, J. (2018). NeuroImage: Clinical, 19, 106–121.
- Keynan, J. N., et al. (2019). Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience. Nature Human Behaviour, 3(1), 63–73. https://doi.org/10.1038/s41562-018-0484-3
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Not identified or not verified: NICE, EMA, MHRA or professional-body guidance on rtfMRI-nf; any later deCharms chronic-pain trial; the original FDA 510(k) summary for Prism; BCIA certification pages [uncertain].