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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00842-55 | Other Identifier | ID-RCB number, ANSM |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal MRI-guided rTMS | Experimental |
| |
| Conventional T3-P3 rTMS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagPro X100 repetitive Transcranial Magnetic Stimulation | Device | Target defined using both fMRI during hallucinations occurence and tractography. Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session |
| Measure | Description | Time Frame |
|---|---|---|
| Severity and Frequency of Hallucinations | Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate) | Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical State | Clinical Global Improvement [CGI]/ Positive & Negative Symptoms Scale [PANSS]/ Global Assessment of Functioning [GAF]. For the auditory modality: Add the Auditory Hallucinations rating Scale [AHRS] frequency scale and total score/ Add the computerized Binary Scale of Auditory Speech Hallucinations [cbSASH] | Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud Jardri, M.D., Ph.D. | Lille University Medical Centre, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lille University Hospital Centre | Lille | F-59037 | France | |||
| Saint-Anne Psychiatric Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25733569 | Result | Demeulemeester M, Kochman F, Fligans B, Tabet AJ, Thomas P, Jardri R. Assessing early-onset hallucinations in the touch-screen generation. Br J Psychiatry. 2015 Mar;206(3):181-3. doi: 10.1192/bjp.bp.114.154153. | |
| 28660668 | Derived | Leroy A, Foucher JR, Pins D, Delmaire C, Thomas P, Roser MM, Lefebvre S, Amad A, Fovet T, Jaafari N, Jardri R. fMRI capture of auditory hallucinations: Validation of the two-steps method. Hum Brain Mapp. 2017 Oct;38(10):4966-4979. doi: 10.1002/hbm.23707. Epub 2017 Jun 28. |
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| ID | Term |
|---|---|
| D006212 | Hallucinations |
| D012559 | Schizophrenia |
| D010468 | Perceptual Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| MagPro X100 repetitive Transcranial Magnetic Stimulation | Device | Target: T3-P3 (10-20 EEG international System). Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session |
|
| MRI changes | structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy | Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1) |
| Paris |
| 75005 |
| France |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |