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The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil.
The patient will receive treatment arm A or B :
Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies.
20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| classic rTMS treatment | Active Comparator | Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy |
|
| treatment with deep rTMS | Active Comparator | Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| classic rTMS using the 8-shaped coil | Device | 20 rTMS sessions are planned (5 sessions per week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| A 50% change of MADRS score | The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. Modification of the MADRS score compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score >34 being severe depression. | Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghina HARIKA-GERMANEAU, Dr | Contact | 0033 5 16 52 61 18 | ghina.harika-germaneau@ch-poitiers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Ghina HARIKA-GERMANEAU, Dr | Centre Hospitalier Henri Laborit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Henri Laborit | Recruiting | Poitiers | France |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| deep rTMS using the H1-shaped coil | Device | 20 rTMS sessions are planned (5 sessions per week) |
|