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

Launched by DOMINIQUE JANUEL · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two types of brain stimulation treatments to help people who have severe depression that hasn't improved with traditional medications. The researchers want to find out if one treatment, called Figure Eight-Coil TMS (which uses a specific type of brain stimulation known as rTBS), is more effective than another treatment called H-Coil TMS (hTBS) in helping patients feel better. Participants in the trial will receive a total of 8 sessions of stimulation each day for 5 days, along with regular check-ups and MRI scans before and after the treatment. They will also have follow-up visits via video call at different intervals over the next year.

To be eligible for this trial, participants must be at least 18 years old and have a diagnosis of major depressive disorder that hasn’t responded to at least two different antidepressant treatments. They also need to be stable on their current treatment for at least six weeks. However, certain conditions like epilepsy, severe addiction issues, or being pregnant will exclude someone from participating. This trial is important as it could lead to better treatment options for those struggling with resistant depression.

Gender

ALL

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