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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
repetitive transcranial magnetic stimulation
DeviceA 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.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: rTMS ARMOther 1 intervention
Group B: hTBS ArmOther 1 intervention
Trial outcomes
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
Time frame
Before the treatment and after the treatment at 5 day.Secondary outcomes
1
Clinical improvement of treatment-resistant depression
We use: \- MADRS (Montgomery-Åsberg Depression Rating Scale) : Remission: A MADRS score of less than 10.
Time frame
Before the treatment and after the treatment at 5 days.2
Clinical improvement of treatment-resistant depression
We use: \- HDRS-17 (Hamilton Depression Rating Scale - 17 items): The scale contains 17 items, each scored on a scale from 0 to 4, 0 to 2, or 0 to 3, depending on the item. The total score is obtained by adding the scores of all 17 items. The total score can range from 0 to 52. Response: A reduction of 50% or more in the total HDRS-17 score compared to baseline is generally considered a response to treatment. Remission: A score of 7 or less is typically considered remission from depression.
Time frame
Before the treatment and after the treatment at 5 days.3
Clinical improvement of treatment-resistant depression
We use: \- QIDS-SR : The patient answers the 16 items, each assessing various depressive symptoms, and the score ranges from 0 to 27, based on their experiences over the past week. A 50% reduction in the total score from baseline is considered a response.
Time frame
Before the treatment and after the treatment at 5 days.4
Clinical improvement of treatment-resistant depression
We use: \- EQ5D : The EQ-5D is a brief tool for assessing health-related quality of life. It measures 5 key dimensions of health.
Time frame
Before the treatment and after the treatment at 5 days.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dominique JANUEL
Lead sponsor
Centre hospitalier de Ville-Evrard, France
Sponsor institution
Source ClinicalTrials.gov
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