External trigeminal nerve stimulation for ADHD (Monarch eTNS)

Domain IX · Biomedical, neuro & digital · 2019 · USA

What it is

The FDA classification, special controls and risks to health are as set out in the FDA's final classification order in the Federal Register (2021). The UK trial was checked against the Nature Medicine abstract, the ISRCTN registry record, King's College London's results release and the published…

Format

• Pilot authors' own caveats: a small developmental sample; only acute (4-week) response; no study of use alongside standard treatments; about half of treated children had clinically meaningful improvement; benefits faded in a week off treatment. Unexplained weight and pulse increases were seen in…
• Before any decision (1–2 sessions, parents with and without the child): clarify the diagnosis and who made it; map current psychosocial support; give balanced psychoeducation that includes the contested evidence; refer to or liaise with the prescriber. Move on when the family has a named…

Who practises it, and how they are trained or regulated

• United States, original authorisation: FDA De Novo marketing authorisation for NeuroSigma's Monarch eTNS System, announced 19 April 2019. The FDA called it the first non-drug ADHD treatment it had authorised. De Novo is the route for new low-to-moderate-risk device types, and it created a new classification that later devices can use through 510(k). The FDA's final order records that NeuroSigma's De Novo request…
• UK phase 2b trial (ATTENS, published 2026): a double-blind, randomised, parallel-group trial of 150 young people aged 8 to 18 with a clinical ADHD diagnosis, split evenly between real and sham stimulation, recruited through CAMHS clinics in five NHS trusts and run from London and Southampton; sponsored by King's College London and South London and Maudsley NHS Foundation Trust, funded by the NIHR/MRC Efficacy and…
• Contested: the manufacturer argues that the UK trial's parent-rated primary outcome may have limited what it could detect. It points to an ongoing UCLA double-blind trial of about 225 children with clinician-rated outcomes, with results expected in 2026. That US trial is registered as NCT05374187 ("Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD"). It is sponsored by UCLA, runs at UCLA and…

Evidence status, as the guide reports it

• UK: NICE guidance does not recommend TNS for ADHD. NICE NG87 covers psychosocial treatment and medication and does not cover eTNS. The authors of the UK trial report that NICE has said stronger evidence would be needed before such devices could be recommended on the NHS. No MHRA/UKCA status for an…

Questions to explore with your client

• What drew you to it, and what are you hoping it will change?
• Does it involve any substance, plant preparation, remedy or supplement? Has your doctor or prescriber been told, especially about any medication you take?
• Is it a group, retreat or community? How do they respond if someone wants to leave or raises a concern?
• How do you and the practitioner understand what is happening, in spiritual or cultural terms? Is that a source of comfort, worry, or both?
• Does it use a device, heat, cold, water or a physical procedure? Has a medical professional checked that it is safe for you?
• Who runs it, and what training or registration do they hold?
• What actually happens in a session or meeting, and how often?
• What does it cost, and is there pressure to commit to more?
• How do you feel afterwards, in the hours and days that follow?
• Does it fit with, or clash with, the work we do here?

What practitioners of it watch for

• hopelessness ('nothing works'), or blaming the child.
• siblings using the device; adults borrowing it; online advice to adapt general-purpose TENS units.
• new or worse sleep problems, nightmares, or daytime drowsiness at school. Record these and pass them on (B8).
• guilt or conflict between parents; a child pressured into nightly use; families feeling they 'failed' the device.
• parents downplaying side effects because they badly want a non-drug option, or a child hiding discomfort to please the parent.

When to involve someone else

• New or worsening physical symptoms, or advice to stop or change prescribed medication: involve the client's doctor or prescriber.
• Signs of coercion, isolation from family and friends, escalating costs or secrecy: discuss openly and consider safeguarding.
• A crisis or thoughts of suicide: follow your crisis protocol. In the US, call or text 988; in the UK and Ireland, Samaritans on 116 123.

Drawn automatically from the guide's own sections. Stay curious: neither endorse nor dismiss what the client values, and check anything that matters against the full guide and its sources. Not medical advice.