Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
Recruiting now · Not applicable
Conditions studied: Depressive Disorder, Treatment-Resistant
In brief
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. The patient will receive treatment arm A or B : Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies. 20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.
Key facts
- Study ID
- NCT04956016
- Run by
- Centre Hospitalier Henri Laborit
- People needed
- 152
- Starts
- 2021-08-23
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-01-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Centre Hospitalier Henri Laborit — Poitiers, France (enrolling)
Full record on ClinicalTrials.gov
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