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This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Frequency Left repetitive | Active Comparator | High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100 |
|
| intermittent Theta Burst Stimulation (iTBS) | Experimental | intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic response rate | Primary outcome will be therapeutic response rate corresponding to with MADRS score improvement > 50 % in each group at the end of TMS sessions and one month after. A final score of <8 is categorized as remission. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate | 6 months | |
| Quality of life | 6 months | |
| Measures of cortical excitability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Bulteau, dr | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44093 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28086851 | Derived | Bulteau S, Sebille V, Fayet G, Thomas-Ollivier V, Deschamps T, Bonnin-Rivalland A, Laforgue E, Pichot A, Valriviere P, Auffray-Calvier E, Fortin J, Pereon Y, Vanelle JM, Sauvaget A. Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial. Trials. 2017 Jan 13;18(1):17. doi: 10.1186/s13063-016-1764-8. |
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| 6 months |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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