Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia

Официальное название

Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transcranial direct current stimulation (tDCS) active
  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.
• Устройство Transcranial direct current stimulation (tDCS) non active
  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.

Первичные конечные точки

• cannabis use [Срок оценки: 6 months]

Вторичные конечные точки (5)

• cannabis use [Срок оценки: 3 months]
• Change in craving scores [Срок оценки: 3 months and 6 months]
• Hospitalizations [Срок оценки: 6 months]
• Study of structural cerebral connectivity [Срок оценки: 3 months]
• Study of structural and functional cerebral connectivity [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Schizophrenia diagnostic according to DSM (Diagnostic and Statistical Manual of mental disorder) 5 criteria, without change in psychotropic treatment since at least 4 weeks
• Moderate to severe cannabis use disorder according to DSM 5 criteria and active consumption during the last 7 days
• Subjects motivated to reduce or quit their cannabis consumption
• Patients with ambulatory compulsory care may be included

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 8 центров

• CH Le Vinatier Service universitaire d'addictologie de Lyon — Bron
• Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles — Clermont-Ferrand
• CHU de Clermont-Ferrand Service de Psychiatrie — Clermont-Ferrand
• Service Hospitalo-Universitaire d'Addictologie CHU de Dijon — Dijon
• CHU Pôle de Psychiatrie Neurologie et Rééducation — La Tronche
• CH Saint-Cyr-au-Mont-d'Or service de psychiatrie — Saint-Cyr-au-Mont-d'Or
• Centre Hospitalier Alpes Isère — Saint-Égrève
• CHU de Saint-Etienne — Saint-Priest-en-Jarez

Идентификаторы

NCT: NCT04871048 · 19PH229 · 2020-A02976-33

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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