Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment (HAUVERDEEP)

Centre Hospitalier Henri Laborit

Status: Enrolling

Conditions: Depressive Disorder, Treatment-Resistant

Treatments: Device: classic rTMS using the 8-shaped coil; Device: deep rTMS using the H1-shaped coil

Study type: Interventional

Funder types: Other

Identifiers

NCT04956016

2021-A00796-35

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

classic rTMS treatment

Active Comparator group

Description:

Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy

Treatment:

Device: classic rTMS using the 8-shaped coil

treatment with deep rTMS

Active Comparator group

Description:

Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies

Treatment:

Device: deep rTMS using the H1-shaped coil