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Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Henri Laborit
NCT04956016 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • classic rTMS using the 8-shaped coil
  • deep rTMS using the H1-shaped coil
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Where

1 site
Centre Hospitalier Henri Laborit
Poitiers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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