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New Helmet-Style brain stimulation may beat standard treatment for resistant depression

NCT ID NCT04956016

Symptom relief Sponsor: Centre Hospitalier Henri Laborit Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a newer 'deep' magnetic stimulation helmet works better than the standard coil for people with depression that hasn't improved with medication. 152 adults will receive 20 sessions over 4 weeks and be followed for 90 days. The goal is to see which method reduces depression symptoms more effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rTMS (repetitive transcranial magnetic stimulation) using either a standard 8-shaped coil or a deep H1-shaped coil
What this could lead to
If deep rTMS proves more effective, it could offer a better non-drug option for people with depression that hasn't responded to medication.
What could go wrong
This is a relatively small, early-stage comparative study. The results may not apply to all patients, and neither treatment is guaranteed to work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 152 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Volunteer subjects over 18 years old * Having signed a free and informed consent * Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994). * Having an antidepressant treatment not modified since 3 weeks * Score to MADRS scale ≥ 21 * Subject affiliated to a social security regimen Exclusion Criteria: * Depression with psychotic caracteristics * Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime) * Patient who has already undergone seismotherapy for current episode and non-responder to this treatment * Patient hospitalized under duress or under legal protection (guardianship, curatorship) * Patient with a high risk of suicide (item 10 of MADRS \> 4) in the absence of hospitalization. * Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip * Pregnancy * Simultaneous participation to another interventionnal study

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Conditions

The condition(s) this trial relates to.

depressive disorder Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, treatment-resistant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Henri Laborit

    RECRUITING

    Poitiers, France

More trials for these conditions

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