Supraorbital and sphenopalatine-ganglion stimulation

1. Introduction

Version followed: the official regulatory and guidance descriptions as of October 2026. For external trigeminal (supraorbital) stimulation these are the FDA De Novo authorisation of March 2014 and the FDA 510(k) clearance of Cefaly Dual for over-the-counter use, K201895 (29 September 2020), plus NICE IPG740 (26 October 2022). For sphenopalatine ganglion (SPG) stimulation they are NICE IPG527 (26 June 2015) and its NICE overview, together with reports on the Pulsante system (Autonomic Technologies, Inc.). This guide gives no stimulation settings, intensities, session lengths or placement details. Those belong to the device labelling and the treating headache team.

What these are. These are two neuromodulation devices for primary headache disorders. In both, a neurologist or headache service, not the psychotherapist, prescribes, implants, supervises or recommends the device.

• External trigeminal / transcutaneous supraorbital nerve stimulation (e-TNS; Cefaly is the named product). The FDA describes it as a small, portable, battery-powered headband worn across the forehead. A self-adhesive electrode on the forehead stimulates branches of the trigeminal nerve. The user may feel tingling or a massage-like sensation [source: MD+DI 2014 on the FDA De Novo authorisation]. Current US indications are acute treatment of migraine with or without aura and prevention of episodic migraine, in people aged 18 or over, sold over the counter [source: FDA K201895 summary via Innolitics].
• Sphenopalatine ganglion stimulation (Pulsante SPG Microstimulator System) for chronic cluster headache. A small stimulator is implanted under general anaesthesia through a cut in the gum. Its lead sits in the pterygopalatine fossa next to the SPG, and its body is fixed near the cheekbone. During an attack the patient holds a handheld controller against the cheek to switch it on [source: NICE IPG527 guidance document, ORA copy].

How change is thought to happen (as sources state it). Both devices act on nerve structures involved in headache pain: branches of the trigeminal nerve for e-TNS, and the SPG, a nerve bundle behind the nose, for SPG stimulation [source: MD+DI 2014; INS SPG page]. In the FDA's account, e-TNS reduced migraine days and the use of attack medication compared with a placebo device. It did not stop migraine completely and did not make the remaining attacks less intense [source: MD+DI 2014]. Psychologically, what changes is mainly the person's sense of control over attacks, less reliance on medication, and how well they cope with uncertainty about whether the device works for them [synthesis].

Regulatory status (checked October 2026).

What this means in practice: in the US, a client can buy e-TNS without a prescription. A client in England is more likely to meet it through a headache service working under NICE special arrangements, or to buy it privately [synthesis]. SPG stimulation is a specialist-centre or research treatment. A client asking about it should be pointed to a headache centre, not given an opinion on availability [synthesis].

2. Framework

The psychotherapist does not run the device treatment. The framework below sets the therapist's work alongside the treating team's pathway. The team's steps come from the sources; how the therapist's work fits around them is [synthesis].

Phase A: Before the device (assessment and decision).

• Team's tasks: diagnosis, patient selection (migraine expertise for e-TNS; a multidisciplinary refractory-headache team for SPG stimulation), written information, and consent that covers uncertainty and other options [source: NICE IPG740; NICE IPG527].
• Therapist's goals: help the client understand what the device can and cannot do. Support shared decision-making. Assess mood, anxiety, suicidality and coping. Set a baseline for headache-related disability and distress. Continue or begin behavioural headache treatment.
• Format: usually 1–3 sessions on top of existing therapy [synthesis].
• Move on when the client has a decision made with the team, and a shared plan for what to watch and whom to contact.

Phase B: Starting and early use.

• e-TNS: the client starts using the device as labelled. The therapist never coaches settings.
• SPG stimulation: the implant operation, then a period when most adverse events appear. In the NICE evidence most occurred within 30 days and usually resolved [source: NICE IPG527 document].
• Therapist's goals: track side effects, mood, expectations and how the client uses the device and their attack medication (descriptively). Pass relevant observations to the team.
• Format: regular sessions, for example weekly or fortnightly. Brief check-ins can be added in the first weeks after an implant [synthesis].

Phase C: Judging response.

• The team judges whether the device helps; the therapist does not.
• The therapist helps the client keep a headache diary the team can use, and works through disappointment, partial response or ambivalence. They support the client to bring questions back to the team [synthesis].
• NICE's research recommendations name the outcomes that matter: migraine frequency and severity, quality of life, changes in medication, and complications [source: NICE IPG740].

Phase D: Maintenance, discontinuation or ending.

• Behavioural headache treatment is consolidated. A relapse and flare plan is made.
• If the device is stopped, the therapist supports the client through any sense of loss or failure. SPG implants may need revision or removal: in NICE's evidence, revision or removal occurred in 16% of trial patients between 30 days and 1 year [source: NICE IPG527 document].
• Ending criteria: stable coping, a working flare plan, and agreed contact routes with the team [synthesis].

3. Guiding principles

[source: NICE IPG740 and IPG527 for consent and selection; AHS Behavioral Treatment page for combining behavioural care with medical care; others synthesis]

• Stay in your lane on the device. Never comment on settings, placement, frequency of use or stopping. Practical meaning: every technical question goes back to the prescriber or headache team.
• Uncertainty is part of consent. NICE asks clinicians to make sure patients understand the remaining uncertainties about safety and efficacy. Practical meaning: help the client hold realistic expectations, for example fewer migraine days rather than none [source: NICE IPG740; MD+DI 2014].
• Shared decision-making. NICE requires clear written information and NICE public information for patients. Practical meaning: help clients read, question and bring that material to appointments.
• Behavioural treatment runs alongside, not instead. The AHS notes that behavioural therapies are often prescribed together with acute or preventive treatments. Practical meaning: keep CBT, relaxation, biofeedback or mindfulness going whatever the device decision [source: AHS Behavioral Treatment for Migraine].
• Observe and pass on; don't diagnose. Practical meaning: note side effects, mood changes and new symptoms, and route them to the team, with the client's consent where possible.
• Watch risk, especially in cluster headache. Practical meaning: chronic, refractory, very severe pain calls for routine and repeated suicide-risk assessment [synthesis; standard risk-assessment practice].
• Respect self-purchase. In the US the device is sold over the counter. Practical meaning: a client may use e-TNS without medical oversight, so encourage them to tell their headache clinician and to use it only as labelled [synthesis].
• Don't make the device a test of the client. Practical meaning: frame non-response as information about the treatment, not as the client failing or as evidence that the pain is 'psychological' [synthesis].
• Collaboration is documented. Practical meaning: keep a record of consent to share, of contacts with the team and of what was passed on [synthesis].

4. Intervention inventory

Part A describes how the treating team delivers each device. It stays at a descriptive level, as regulators and NICE publish it, and gives no settings. Part B covers the psychotherapist's own interventions.

A1. External trigeminal (supraorbital) stimulation: how it is delivered

• Purpose: Acute treatment of migraine attacks and prevention of episodic migraine in adults aged 18 and over (US labelling) [source: Innolitics K201895]. In England, NICE allows acute use only with special arrangements and preventive use only in research [source: NICE IPG740].
• Steps (descriptive only):
  • A clinician with migraine expertise diagnoses the condition and, in NHS practice, selects the patient [source: NICE IPG740].
  • In England, the client receives written information, including NICE's public information, before deciding [source: NICE IPG740].
  • The client wears a headband device over a self-adhesive electrode on the forehead and uses it as the product labelling instructs. Session details are in the labelling and are not given here [source: MD+DI 2014].
  • Under NICE special arrangements, outcomes are audited and safety data collected [source: NICE IPG740].
• Example language (illustrative): "Your neurologist or the instructions are the place for how and when to use it. What I can help with is how you are getting on with it, and what you notice."
• Watch for: Use that goes beyond the labelling. Use of the device instead of seeking care for a new or changed headache [synthesis].

A2. External trigeminal stimulation: official safety information

• Purpose: To know which warnings the therapist may need to recognise and pass on.
• Content as FDA special controls require in the labelling [source: Innolitics K201895, special controls for 21 CFR 882.5891]:
  • Not for people with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator.
  • Warnings against putting the device on the neck or chest, and against using it near electronic monitoring equipment, in the bath or shower, while asleep, while driving or while operating machinery.
  • A statement that the long-term effects of chronic use are unknown.
• Other safety statements: No adverse events were reported in the trial behind the 2014 authorisation, and tingling or a massage-like sensation is expected [source: MD+DI 2014]. NICE found no major safety concerns [source: NICE IPG740]. The product's own list of side effects and its rules on pregnancy and children are not drawn on here; check the current instructions for use [uncertain].
• Example language (illustrative): "You mentioned you use it in the car on the way to work. The safety information says not to use it while driving. Could you check that with your headache nurse?"
• Watch for: Use while driving. A client who has or is getting a cardiac or head implant. Skin problems at the electrode site, which should go to the clinician or pharmacist [synthesis].

A3. Sphenopalatine ganglion stimulation: how it is delivered

• Purpose: Acute treatment of attacks in chronic cluster headache that does not respond to medical treatment. NICE notes that most people respond to medical treatment, but a small number have very distressing symptoms and few options [source: NICE IPG527 document].
• Steps (descriptive only) [source: NICE IPG527 document]:
  • A multidisciplinary team specialising in refractory headache selects and manages patients.
  • Consent covers uncertain safety and long-term benefit, written information and other treatment options.
  • Under general anaesthesia, the device is implanted through a small cut in the gum on the affected side. X-ray guidance is used to place the lead next to the SPG in the pterygopalatine fossa, and the body of the device is fixed near the cheekbone. The device is tested during the operation.
  • To treat an attack, the patient holds a handheld controller on the cheek over the implant, up to a limit the team sets.
  • Outcomes are audited, and the patient is entered on the national neuromodulation register.
• Status caveat: NICE states the device had no current CE mark as of August 2019. UK use is then limited to MHRA- and ethics-approved clinical investigations [source: NICE IPG527 page]. Current availability elsewhere is [uncertain].
• Example language (illustrative): "That sounds like a question for the headache centre: whether this is available and whether you'd be eligible. Shall we write down what you'd want to ask them?"

A4. Sphenopalatine ganglion stimulation: official safety information

• Adverse events reported in NICE's evidence summary [source: NICE IPG527 document], qualitatively:
  • Sensory disturbances: numbness, tingling, abnormal or painful sensation. Very common in the first 30 days; many resolved.
  • Pain in the face, cheek, gum, jaw joint, nose or around the eye.
  • Swelling. Restricted jaw opening (trismus). Dry eye. Mild facial weakness. Infection, which resolved with antibiotics.
  • Non-cluster headache.
  • Occasional nosebleed, tearing, taste change, reduced gag reflex.
  • Lead revision or removal, for poor positioning, dislodgement, maxillary nerve pain, misplacement or infection.
• Specialist advisers considered damage to nearby structures, such as the sinuses, a theoretical risk.
• Problems with the device should be reported to the MHRA through the Yellow Card Scheme [source: NICE IPG527 page].
• Watch for (therapist): Facial numbness or pain after the operation that worries the client. Signs of infection. New headaches. Low mood or hopelessness if the implant does not help. Pass all of these to the implanting team [synthesis].

B1. Recognising when to suggest medical review or referral

• Purpose: To make sure headache problems and device problems reach the right clinician.
• When: A new, changed or worsening headache pattern. Escalating use of attack medication. New neurological symptoms. Side effects of a device. A client who bought a device with no clinician involved. Interest in SPG stimulation [synthesis].
• Steps:
  1. Name what you noticed, factually.
  2. Ask whether the headache team knows about it.
  3. Agree who will contact whom and by when: the client, you with consent, or both.
  4. Record it, and follow up next session.
• Example language (illustrative): "That's a change from what you've described before. I'm not the person to judge what it means, but your neurologist should hear about it. Would you call this week, or would you like me to write to them?"
• Watch for: Being reassured on medical matters. Urgent symptoms, such as a sudden severe headache or neurological deficits, which go to emergency services, not to the next appointment [synthesis].

B2. Psychoeducation about the device

• Purpose: To give an accurate, balanced picture so the client has realistic expectations.
• Steps:
  1. Ask what the client already knows and where it came from: advertising, forums, a clinician.
  2. Correct misunderstandings using official sources. For example, e-TNS reduced migraine days and attack-medication use in the 2014 trial but did not stop migraines completely or make remaining attacks less intense [source: MD+DI 2014]. NICE considers preventive use in England a matter for research [source: NICE IPG740].
  3. Explain who decides what: the team decides about the device; the therapy works on coping, mood and behaviour.
  4. Point to official patient information (NICE public information, manufacturer instructions) [source: NICE IPG740].
• Example language (illustrative): "The studies suggest some people have fewer migraine days, but it doesn't make migraine disappear. It may be one tool among several."
• Watch for: All-or-nothing hopes ('this is my last chance'). Commercial claims treated as established fact [synthesis].

B3. Supporting informed consent and shared decision-making

• Purpose: To help the client make a decision that fits their values, using what the team tells them.
• Steps:
  1. List the options the team has offered, including continuing current care [source: NICE IPG527 requires that other options be discussed].
  2. Explore what matters to the client: avoiding medication, cost, avoiding surgery, and tolerating uncertainty.
  3. Help them write questions. For SPG stimulation: likely side effects, what happens if it doesn't work, removal, registry entry, follow-up. For e-TNS: how response will be judged, and whether it fits with their medication.
  4. Rehearse the conversation with the clinician if anxiety gets in the way.
  5. Never recommend for or against the device [synthesis].
• Example language (illustrative): "What would make this worth trying for you, and what would make it not worth it?"
• Watch for: Consenting under pressure or out of despair. Difficulty taking in risks during severe pain. If capacity seems affected at the time of decision, raise it with the team [synthesis].

B4. Monitoring and passing on adverse effects and mood

• Purpose: To be a second set of eyes between appointments.
• Steps:
  1. At each session, ask briefly about device use, side effects, attacks and medication use, and record what the client says.
  2. Screen mood, anxiety, sleep and suicidal thinking using your usual validated tools.
  3. Get consent at the outset to share relevant observations with the headache team.
  4. Pass on: possible adverse effects (see A2 and A4), worsening mood, suicidality, rising use of attack medication, and use outside the labelling.
  5. Close the loop: confirm the team received it [synthesis].
• Example language (illustrative): "Before we start, a quick check: how has the stimulator been this week? Any soreness, numbness, anything new?"
• Watch for: Clients who minimise side effects to avoid losing the device. Mood dropping when relief is less than hoped [synthesis].

B5. Headache diary as a shared monitoring tool

• Purpose: To give the team usable data, and to give the client a less catastrophic view of the pattern.
• Steps:
  1. Use the diary format the headache team uses, or one they approve.
  2. Record attack days, severity, attack-medication use, device use (yes or no only), triggers, mood and sleep.
  3. Review it in session for patterns and coping, not for device dosing.
  4. The client takes the diary to medical appointments.
• NICE's research recommendations list migraine frequency and severity, quality of life, medication changes and complications as the relevant outcomes [source: NICE IPG740]. The diary method itself is [synthesis].
• Example language (illustrative): "Let's look at the month as a whole rather than the worst day."
• Watch for: Diary keeping that turns into hypervigilance about pain. Shorten the diary if this happens [synthesis].

B6. Conversations about adherence and ambivalence

• Purpose: To explore mixed feelings about using the device, without advising any change.
• Steps:
  1. Reflect both sides: hope and scepticism, cost and inconvenience, side effects.
  2. Ask what the client has told the team.
  3. If the client wants to stop, use differently or start a device, route the decision to the prescriber. Help them prepare that conversation.
  4. Use motivational-interviewing style reflections. Never 'you should keep using it' or 'you could stop' [synthesis].
• Example language (illustrative): "Part of you is fed up with wearing it, and part of you worries the migraines will get worse without it. That is worth taking to your neurologist. What would you want them to know?"
• Watch for: Stopping or overusing in secret. Shame about 'not doing it right' [synthesis].

B7. Integrating behavioural headache treatment

• Purpose: Behavioural treatment for migraine has a large evidence base and is often prescribed together with acute or preventive treatments [source: AHS Behavioral Treatment for Migraine].
• Components the AHS names: cognitive behavioural therapy, biofeedback, relaxation techniques, mindfulness ("paying attention in the present moment without judgment"), and healthy lifestyle habits including sleep, exercise and stress reduction [source: AHS Behavioral Treatment for Migraine]. Session formats and counts were not given there [uncertain].
• Steps (integration) [synthesis]:
  1. Continue or start the behavioural package whatever is decided about the device. Present it as an addition, not a competing treatment.
  2. Time the work: relaxation and attention skills can be practised between attacks. During an attack, keep to the acute plan the team agreed.
  3. Address sleep. The AHS notes that people with headache disorders have a 2–8 times greater risk of sleep disorders [source: AHS page]. Refer to a sleep service if needed.
  4. Use CBT for catastrophising, fear of attacks, avoidance and mood.
  5. For cluster headache, focus on coping with anticipatory dread and recovering after an attack, plus mood and sleep. The evidence here is migraine-specific; cluster applications are [synthesis].
  6. Biofeedback, if offered, by a trained practitioner (see Domain IX biofeedback entries).
• Example language (illustrative): "The device works on the nerve side. What we do here works on the stress, sleep and fear side. They can work together."
• Watch for: The client or team treating behavioural work as 'it's all in your head'. Name it as evidence-based care for a neurological condition [synthesis].

B8. Psychological support around the SPG implant (before and after surgery)

• Purpose: To help the client through the operation, the early adverse-event period and the evaluation period.
• Steps [synthesis]:
  1. Before surgery: work on worries about the operation, and about trismus, numbness or facial pain (A4). Help the client write questions for the surgeon.
  2. Agree a plan for the first 30 days, when most adverse events occurred in NICE's evidence [source: NICE IPG527 document]: who to call, and what to report.
  3. After surgery: check sensory changes, pain, eating difficulty (trismus), body image (facial asymmetry or weakness) and mood. Pass on concerns.
  4. Prepare for possible revision or removal (A4) as a recognised outcome, not a personal failure.
• Example language (illustrative): "Numbness and soreness were common early on in the studies. Still, tell the team about anything that worries you; don't wait."
• Watch for: fears about facial changes, eating difficulty or numbness that lead to avoidance or low mood. Working if the client reports problems to the team promptly and keeps up valued activities [synthesis].

B9. Crisis and safety planning

• Purpose: People with severe refractory headache can become hopeless. Routine risk assessment is standard practice [synthesis].
• Steps:
  1. Assess suicidal thoughts directly at baseline, at each change in treatment, and when relief disappoints.
  2. Make a written safety plan: warning signs (for example the start of a cluster bout), coping steps, contacts, the headache team and crisis lines.
  3. Lethal-means counselling: safe storage and limited stockpiles of medicines, agreed with the client and prescriber, without method detail.
  4. Urgent risk goes through the local crisis pathway. Inform the GP or neurologist with consent, or without it where the law and policy require [synthesis].
• Example language (illustrative): "When the attacks are at their worst, do you ever think about not wanting to be here? Many people with this kind of pain do, and it helps to have a plan."
• Watch for: hopelessness at the start of a bout or after disappointing results, and stockpiling of medicines. Working if the plan is used and updated [synthesis].

B10. Self-purchase and do-it-yourself use

• Purpose: In the US, e-TNS is sold over the counter [source: Innolitics K201895], so clients may use it without a clinician.
• Steps [synthesis]:
  1. Ask about any devices bought online.
  2. Encourage the client to tell their headache clinician and to follow the labelling, including the contraindications and warnings in A2.
  3. Discourage home-made or off-label electrical stimulation. Specific DIY risks are [uncertain]. Unregulated devices have no safety controls equivalent to the FDA's.
• Example language (illustrative): "It's sold without a prescription, but your neurologist still needs to know you're using it, especially alongside your medication."
• Watch for: several devices or methods used without the clinician knowing, and any home-made electrical stimulation. Working if the headache clinician knows everything the client uses [synthesis].

B11. Support after treatment ends

• Purpose: To consolidate coping when a device is stopped, removed or no longer available. For example, SPG device availability changed after the CE mark lapsed [source: NICE IPG527 page].
• Steps [synthesis]:
  1. Review what helped: device and non-device.
  2. Address grief, anger or hopelessness about losing a treatment.
  3. Update the flare and safety plan.
  4. Agree a follow-up or booster schedule and a route back to the headache service.
• Example language (illustrative): "Losing access to something that helped is a real loss. Let's look at what you still have in your toolkit."
• Watch for: loss of hope, or rising use of acute medicines after a device stops, which goes to the prescriber. Working if the client keeps using non-device coping and the flare plan [synthesis].

5. Handling problems

All guidance in this section is [synthesis] unless a source is named.

• Client asks you for settings or how to use the device. Decline warmly, give the reason (it's outside your role, and the labelling and team are authoritative), and help them prepare the question for the team.
• Disappointment or no response. Normalise it: the device did not prevent migraine completely in the trial behind the FDA authorisation [source: MD+DI 2014]. Look for all-or-nothing thinking. Screen mood and suicidality (B9). Route the question of whether to continue to the team.
• Client wants to stop medication because they now have a device. Do not agree or disagree. Reflect the wish and route it to the prescriber the same week. Record that you did so.
• Non-adherence (forgetting, discomfort, embarrassment about wearing it). Explore the barriers. Problem-solve only the non-technical ones (routine, privacy, stigma). Technical discomfort goes to the team.
• Health anxiety or hypervigilance about the implant. Use CBT for monitoring and reassurance-seeking, but only after the team has reviewed any new symptoms.
• Overwhelm during a cluster bout. Keep sessions short and practical, or reschedule. Put the agreed acute plan and the safety plan first. Pick up formulation work between bouts.
• 'They think it's psychological' rupture. If the client hears a therapy referral as dismissal, validate it. Say plainly that headache disorders are neurological and that behavioural treatment is an evidence-based part of care [source: AHS Behavioral Treatment for Migraine].
• Team disagreement or poor communication. Keep to observations and the client's words. Ask for a named contact. Avoid triangulating with the client.
• Unavailable or experimental device (SPG stimulation). Give no opinion on access. Direct the client to a specialist headache centre. Explain that in England use is limited to research or special arrangements, as NICE describes [source: NICE IPG527].
• Cost and inequality. Self-funded devices can strain finances. Explore cost-related distress, and do not endorse purchases.
• Use against warnings (driving, sleeping, implanted cardiac devices). Name the labelled warning [source: Innolitics K201895 special controls]. Encourage the client to check with the clinician promptly. If there is immediate danger, follow safety procedures.

Sources

• FDA Clears First Medical Device for Preventing Migraine Headaches (MD+DI, 2014)
• Cefaly Dual K201895 510(k) summary (Innolitics FDA database)
• NICE HTG643 / IPG740: Transcutaneous electrical stimulation of the supraorbital nerve for treating and preventing migraine – recommendations
• NICE IPG740 history page
• NICE IPG527: Implantation of a sphenopalatine ganglion stimulation device for chronic cluster headache
• NICE IPG527 information for the public: About this information
• NICE IPG527 guidance document (Oxford University Research Archive copy)
• Expert consensus on sphenopalatine ganglion stimulation (CNS Neurosurgery Watch, 2014)
• Pathway R-1 registry report on the Pulsante SPG Microstimulator (Medical Design and Outsourcing, 2016)
• Sphenopalatine Ganglion Stimulation (International Neuromodulation Society)
• Behavioral Treatment for Migraine (American Headache Society, primary care resources)

Further reading (not drawn on), marked [uncertain] above: the current Cefaly instructions for use and CE/UKCA and Canadian status; the Pathway CH-2 trial publication; the current company and FDA status of SPG stimulation; the full NICE IPG740 overview.