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

NCT ID: NCT06813313

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-16
• Study Completion Date: 2028-11-18

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

rTMS ARM

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.

Group Type: OTHER

repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

A burst of 3 pulses sent at a frequency of 50 Hz, repeated with a frequency of 5 Hz for 2 seconds, followed by an 8-second pause. This sequence is repeated for 59 cycles, totaling 9 minutes and 50 seconds, with a total of 1800 pulses.

hTBS Arm

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.

Group Type: OTHER

repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

A burst of 3 pulses sent at a frequency of 50 Hz, repeated with a frequency of 5 Hz for 2 seconds, followed by an 8-second pause. This sequence is repeated for 59 cycles, totaling 9 minutes and 50 seconds, with a total of 1800 pulses.

Interventions

repetitive transcranial magnetic stimulation

A burst of 3 pulses sent at a frequency of 50 Hz, repeated with a frequency of 5 Hz for 2 seconds, followed by an 8-second pause. This sequence is repeated for 59 cycles, totaling 9 minutes and 50 seconds, with a total of 1800 pulses.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dominique JANUEL

OTHER

Sponsor Role: lead

Responsible Party

Dominique JANUEL

Head of clinical research department

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Dominique Professor Januel, Professor of Medicine

Role: CONTACT

d.januel@epsve.fr

0143093232 ext. +33143093232

Youcef Bencherif, Project Manager

Role: CONTACT

y.bencherif@epsve.fr

0143093232 ext. +33143093232

Other Identifiers

2024-A00954-43

Identifier Type: -

Identifier Source: org_study_id