Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
NCT ID: NCT04956016
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
152 participants
INTERVENTIONAL
2021-08-23
2028-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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classic rTMS treatment
Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy
classic rTMS using the 8-shaped coil
20 rTMS sessions are planned (5 sessions per week)
treatment with deep rTMS
Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies
deep rTMS using the H1-shaped coil
20 rTMS sessions are planned (5 sessions per week)
Interventions
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classic rTMS using the 8-shaped coil
20 rTMS sessions are planned (5 sessions per week)
deep rTMS using the H1-shaped coil
20 rTMS sessions are planned (5 sessions per week)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Henri Laborit
OTHER
Responsible Party
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Principal Investigators
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Ghina HARIKA-GERMANEAU, Dr
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Henri Laborit
Locations
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Centre Hospitalier Henri Laborit
Poitiers, , France
Countries
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Central Contacts
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Facility Contacts
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Ghina Harika-Germaneau, MD, PhD
Role: primary
Other Identifiers
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2021-A00796-35
Identifier Type: -
Identifier Source: org_study_id
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