Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: classic rTMS using the 8-shaped coil, deep rTMS using the H1-shaped coil.
- Who it may be relevant to
- Registry conditions: Depressive Disorder, Treatment-Resistant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression
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.
Interventions
- Device classic rTMS using the 8-shaped coil
20 rTMS sessions are planned (5 sessions per week) - Device deep rTMS using the H1-shaped coil
20 rTMS sessions are planned (5 sessions per week)
Primary outcome measures
- A 50% change of MADRS score [Time frame: Day 60]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Centre Hospitalier Henri Laborit — Poitiers
Identifiers
NCT: NCT04956016 · 2021-A00796-35