Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871048
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-04-23
Brief Title:
Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CANNAPSYSTIM
Brief Summary:
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
Detailed Description:
Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 75 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A02976-33 | OTHER | ANSM | None |