H1-Coil, Theta Burst Stimulation, Treatment of Resistant Depression
Conditions
Keywords
Resistant Depression, H1-Coil, Theta burst stimulation, TMS, Accelerated Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation with an 8-Coil versus H1-Coil
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.
Interventions
DEVICErepetitive 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.
Sponsors
Dominique JANUEL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The response rate according to the MADRS scale | Before the treatment and after the treatment at 5 day. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain detection and pain tolerance using an experimental pain task | Before the treatment and after the treatment at 5 day. | Cold pain using the cold pressor task and mechanical pain using the algomete |
| Clinical improvement of treatment-resistant depression | Before the treatment and after the treatment at 5 days. | We use: \- MADRS (Montgomery-Åsberg Depression Rating Scale) : Remission: A MADRS score of less than 10. |
| 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. | Rate of adverse effects and rate of premature withdrawal from the study. |
| Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | Trail Making Test A and B (version from the Group for the Evaluation of Executive Functions, GREFEX, Army individual test 1944, based on Godefroy, 2012) |
| Improvement of neurophysiological functions | Before the treatment and after the treatment at 5 day. | Variation in brain functional connectivity between baseline and the end of the rTMS treatment. |
Contacts
Primary ContactDominique Professor Januel, Professor of Medicine
Backup ContactYoucef Bencherif, Project Manager
Outcome results
None listed