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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02976-33 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
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Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.
Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays.
The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS stimulation | Experimental | Transcranial direct current stimulation tDCS-Stimulation will be performed using a Neurocan DC-Stimulator Plus |
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| sham tDCS stimulation | Sham Comparator | Transcranial direct current stimulation tDCS-The control group will receive the sham stimulation following the same regimen, using the sham procedure . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) active | Device | Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays. |
| Measure | Description | Time Frame |
|---|---|---|
| cannabis use | Percentage change in cannabis use before and after tDCS treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| cannabis use | Percentage change in cannabis use before and after 3 months tDCS treatment | 3 months |
| Change in craving scores | Marijuana Craving Questionnaire score (minimum =12, maximum = 84). The higher the score, the greater the craving. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurelia GAY, MD | Contact | (0)4 77 82 88 50 | +33 | aurelia.gay@chu-st-etienne.fr |
| Béatrice DEYGAS | Contact | beatrice.deygas@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aurelia GAY, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Le Vinatier Service universitaire d'addictologie de Lyon | Not yet recruiting | Bron | 69678 | France |
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Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays.
The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
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| Transcranial direct current stimulation (tDCS) non active | Device | The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures. |
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| 3 months and 6 months |
| Hospitalizations | Number of hospitalization(s) during the 6 months after tDCS sessions | 6 months |
| Study of structural cerebral connectivity | Cerebral MRI (only for a subgroup of patients) : Diffusion of water at the white matter level for the evaluation of structural brain connectivity in DTI mode (diffusion tensor) on | 3 months |
| Study of structural and functional cerebral connectivity | Cerebral MRI (only for a subgroup of patients) : Functional connectivity index evaluated by resting state default mode network (MRI) for the evaluation of functional brain connectivity | 3 months |
| Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| CHU de Clermont-Ferrand Service de Psychiatrie | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Service Hospitalo-Universitaire d'Addictologie CHU de Dijon | Not yet recruiting | Dijon | 21079 | France |
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| CHU Pôle de Psychiatrie Neurologie et Rééducation | Not yet recruiting | La Tronche | 38700 | France |
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| CH Saint-Cyr-au-Mont-d'Or service de psychiatrie | Not yet recruiting | Saint-Cyr-au-Mont-d'Or | 69450 | France |
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| Centre Hospitalier Alpes Isère | Not yet recruiting | Saint-Égrève | 38120 | France |
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| CHU de Saint-Etienne | Recruiting | Saint-Priest-en-Jarez | France |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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