Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Cannabis-Induced Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

* active tDCS stimulation. Patients will receive 10 sessions of tDCS over 5 consecutive days, at a frequency of 2 sessions per day spaced at least two hours apart, at an intensity of 2mA, for 20 minutes each.
* tDCS placebo stimulation. Patients will receive 10 sessions of tDCS over 5 consecutive days, at a frequency of 2 sessions per day spaced at least two hours apart, following an identical procedure (tracking, then wearing the device for 20 minutes) but with actual stimulation provided during the first 40 seconds.

Study Groups

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active tDCS stimulation

Transcranial direct current stimulation tDCS-Stimulation will be performed using a Neurocan DC-Stimulator Plus

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS) active

Intervention Type 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.

sham tDCS stimulation

Transcranial direct current stimulation tDCS-The control group will receive the sham stimulation following the same regimen, using the sham procedure .

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS) non active

* Other substance use disorder, excluding nicotine, according to DSM 5 criteria
* Other current psychiatric disorder according to DSM 5 criteria, excluding personality disorder
* Inpatient hospitalization
* History of head injury, neurological disorder with cerebral consequence or severe unstable somatic disorder
* Pregnancy or no contraception
* Contraindications for tDCS and/or MRI (implanted material, uncontrolled epilepsy, intracranial hypertension)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No