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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Depressive Disorder
    Treatment-Resistant

NCT04956016

Centre Hospitalier Henri Laborit

27 January 2024

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