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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS ARM | Other | The treatment consists of 8 sessions per day for 5 days, with daily self-assessments for 1 week. Each session lasts approximately 9 minutes and 50 seconds with a 50-minute break between sessions. The application of rTBS will be done using the Cool-B65 coil, targeting the DLPFC region identified by neuronavigation. |
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| hTBS Arm | Other | The treatment consists of 8 sessions per day for 5 days, with daily self-assessments for 1 week. Each session lasts approximately 9 minutes and 50 seconds with a 50-minute break between sessions. The application of hTBS will be done using the H1 coil, targeting the DLPFC region located 6 cm forward from the motor cortex. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive transcranial magnetic stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Before the treatment and after the treatment at 5 day. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement of treatment-resistant depression | We use: - MADRS (Montgomery-Åsberg Depression Rating Scale) : Remission: A MADRS score of less than 10. | Before the treatment and after the treatment at 5 days. |
| Clinical improvement of treatment-resistant depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Professor Januel, Professor of Medicine | Contact | 0143093232 | +33143093232 | d.januel@epsve.fr |
| Youcef Bencherif, Project Manager | Contact | 0143093232 | +33143093232 | y.bencherif@epsve.fr |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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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. |
| Before the treatment and after the treatment at 5 days. |
| 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. | Before the treatment and after the treatment at 5 days. |
| 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. | Before the treatment and after the treatment at 5 days. |
| Tolerance to treatment | Rate of adverse effects and rate of premature withdrawal from the study. | Each visits of clinical trial : each day of treatment (5 days), at 1 month, 2 month, 3 month, 6 month and 12 month. |
| Improvement of cognitive functions. | 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) | Before the treatment and after the treatment at 5 day. |
| Improvement of cognitive functions. | Free Recall / Cued Recall at 16 items (RL/RI-16), version A or B | Before the treatment and after the treatment at 5 day. |
| Improvement of cognitive functions. | Stroop Test (Golden, 1978) | Before the treatment and after the treatment at 5 day. |
| Improvement of cognitive functions. | Wisconsin Card Sorting Test (WCST), GREFEX version | Before the treatment and after the treatment at 5 day. |
| Improvement of cognitive functions. | N-back Task (version from the Attention Assessment Tests, TAP) | Before the treatment and after the treatment at 5 day. |
| Improvement of cognitive functions. | Go/No-Go Inhibition Task (TAP version) | Before the treatment and after the treatment at 5 day. |
| Improvement of cognitive functions. | Digit Span and "Coding" subtest from the Wechsler Adult Intelligence Scale (WAIS-IV) | Before the treatment and after the treatment at 5 day. |
| Improvement of cognitive functions. | Verbal Fluency Test (GREFEX version) | Before the treatment and after the treatment at 5 day. |
| Improvement of neurophysiological functions | Variation in brain functional connectivity between baseline and the end of the rTMS treatment. | Before the treatment and after the treatment at 5 day. |
| Improvement of neurophysiological functions | Neurobiological/neurophysiological variables: change in heart rate variability. | Before the treatment and after the treatment at 5 day. |
| Improvement of neurophysiological functions | Change in serum BDNF levels. | Before the treatment and after the treatment at 5 day. |
| Improvement of neurophysiological functions | Change in motor cortex neuroexcitability. | Before the treatment and after the treatment at 5 day. |
| Pain detection and pain tolerance using an experimental pain task | Cold pain using the cold pressor task and mechanical pain using the algomete | Before the treatment and after the treatment at 5 day. |