Theta Burst Stimulation With an 8-Coil Versus H1-Coil for Resistant Depression (rTBShTBS)

Dominique JANUEL

Status: Not yet enrolling

Conditions: H1-Coil; Treatment of Resistant Depression; Theta Burst Stimulation

Treatments: Device: repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06813313

2024-A00954-43

Details and patient eligibility

About

The goal of this clinical trial is to compare response rates after treatment with Figure Eight-Coil TMS versus H-Coil TMS on the prefrontal cortex left dorsolateral, in patients suffering from depression resistant. The main question it aims to answer is:

rTBS (accelerated neuronavigated intermittent Theta Burst Stimulation) is more effective than hTBS (accelerated deep intermittent Theta Burst Stimulation) in the treatment of resistant depression in terms of response rate.?

Researchers will compare Figure Eight-Coil TMS (rTBS) versus H-Coil TMS (hTBS) to see if rTBS is more effective than hTBS.

Participants will:

• Receive, for each stimulation method, 8 sessions per day spaced 50 minutes apart, over 5 days.
• Have visit all day of stimulation for checkups and tests.
• Have a a research MRI before and after treatment.
• Have follow-up visits at 1 month, 2 months, 3 months, 6 months, and 12 months post-treatment, via teleconsultation.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age
• Presenting a major depressive episode according to the DSM-5-TR criteria, occurring as part of major depressive disorder (unipolar depression)
• The major depressive episode must meet the criteria for treatment resistance, defined by a lack of response to at least two different antidepressant treatments prescribed at an effective dose for a duration of 6 weeks or more
• Stable treatment for at least 6 weeks
• Affiliation with a social security system or State Medical Assistance (Aide Médicale d'État)
• Patient agrees to participate in the study and has signed an informed consent form

Exclusion criteria

• Presence of a contraindication to TMS: epilepsy, intracranial foreign body, cochlear implant, retinal implant, pacemaker
• Presence of a bipolar disorder according to DSM-5-TR criteria
• Presence of catatonic or psychotic features during the current episode
• Presence of severe psychiatric disorders other than a major depressive episode
• Presence of neurological disorders
• Unstable epilepsy
• Current moderate to severe addiction disorders other than caffeine and/or tobacco
• Current suicidal ideation
• Use of any brain stimulation treatment (ECT, rTMS, tDCS) for the current episode
• Pregnancy or breastfeeding
• Women of childbearing potential without effective contraception
• Persons under guardianship or legal protection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

rTMS ARM

Other group

Description:

The treatment consists of 8 sessions per day for 5 days, with daily self-assessments for 1 week. Each session lasts approximately 9 minutes and 50 seconds with a 50-minute break between sessions. The application of rTBS will be done using the Cool-B65 coil, targeting the DLPFC region identified by neuronavigation.

Treatment:

Device: repetitive transcranial magnetic stimulation

hTBS Arm

Other group

Description:

The treatment consists of 8 sessions per day for 5 days, with daily self-assessments for 1 week. Each session lasts approximately 9 minutes and 50 seconds with a 50-minute break between sessions. The application of hTBS will be done using the H1 coil, targeting the DLPFC region located 6 cm forward from the motor cortex.

Treatment:

Device: repetitive transcranial magnetic stimulation