Theta Burst Stimulation With an 8-Coil Versus H1-Coil for Resistant Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDominique JANUEL
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- repetitive transcranial magnetic stimulation
Treatment groups
108 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Dominique JANUEL
Lead sponsor
Centre hospitalier de Ville-Evrard, France
Sponsor institution
Source ClinicalTrials.gov