Clinical trial NCT06813313: Theta Burst Stimulation With an 8-Coil Versus H1-Coil for Resistant Depression
Official title: Randomized Controlled Trial of Two Accelerated Transcranial Magnetic Stimulation Methods in the Treatment of Resistant Depression: Intermittent Theta Burst Stimulation With an 8-Coil Versus H1-Coil
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The response rate according to the MADRS scale
timeFrame: Before the treatment and after the treatment at 5 day.
Secondary outcomes:
measure: Clinical improvement of treatment-resistant depression
timeFrame: Before the treatment and after the treatment at 5 days.
measure: Clinical improvement of treatment-resistant depression
timeFrame: Before the treatment and after the treatment at 5 days.
measure: Clinical improvement of treatment-resistant depression
timeFrame: Before the treatment and after the treatment at 5 days.
measure: Clinical improvement of treatment-resistant depression
timeFrame: Before the treatment and after the treatment at 5 days.
measure: Tolerance to treatment
timeFrame: Each visits of clinical trial : each day of treatment (5 days), at 1 month, 2 month, 3 month, 6 month and 12 month.
measure: Improvement of cognitive functions.
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of cognitive functions.
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of cognitive functions.
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of cognitive functions.
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of cognitive functions.
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of cognitive functions.
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of cognitive functions.
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of cognitive functions.
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of neurophysiological functions
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of neurophysiological functions
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of neurophysiological functions
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Improvement of neurophysiological functions
timeFrame: Before the treatment and after the treatment at 5 day.
measure: Pain detection and pain tolerance using an experimental pain task
timeFrame: Before the treatment and after the treatment at 5 day.
Other outcomes:
Locations:
Study officials:
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