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

NCT06813313 | Not Yet Recruiting

• 1 other identifier: 2024-A00954-43
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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

Keywords

Resistant Depression; H1-Coil; Theta burst stimulation; TMS; Accelerated Transcranial Magnetic Stimulation; Intermittent Theta Burst Stimulation with an 8-Coil versus H1-Coil

Outcome Measures

Primary Outcomes (1)

• The response rate according to the MADRS scale

  The response rate is defined as an improvement of more than 50% compared to baseline on the MADRS clinical scale (Montgomery-Asberg Depression Rating Scale). The MADRS consists of 10 items, each scored from 0 to 6 : depressive mood, appetite, sleep, psychomotor retardation, anxiety, suicidal thoughts, cognitive impairment, pessimism, loss of control and demoralization. The total score is the sum of the scores for all 10 items. The overall score can range from 0 to 60. 0 to 6: No depression 7 to 19: Mild depression 20 to 34: Moderate depression 35 to 60: Severe depression

  Before the treatment and after the treatment at 5 day.

Secondary Outcomes (18)

• Clinical improvement of treatment-resistant depression

  Before the treatment and after the treatment at 5 days.

• Clinical improvement of treatment-resistant depression

  Before the treatment and after the treatment at 5 days.

• Clinical improvement of treatment-resistant depression

  Before the treatment and after the treatment at 5 days.

• Clinical improvement of treatment-resistant depression

  Before the treatment and after the treatment at 5 days.

• Tolerance to treatment

  Each visits of clinical trial : each day of treatment (5 days), at 1 month, 2 month, 3 month, 6 month and 12 month.

Study Arms (2)

rTMS ARM

OTHER

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.

Device: repetitive transcranial magnetic stimulation

hTBS Arm

OTHER

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.

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation 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; rTMS ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dominique JANUEL: lead

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Dominique Professor Januel, Professor of Medicine

CONTACT

0143093232; d.januel@epsve.fr

Youcef Bencherif, Project Manager

CONTACT

0143093232; y.bencherif@epsve.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinical research department

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 6, 2025
• Study Start: February 16, 2025
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): November 18, 2028
• Last Updated: February 6, 2025

Record last verified: 2025-02