Project on tDCS Intervention to Enhance Advanced Social Cognitive Functions in Drug Rehabilitation Individuals

Обзор

This project aims to explore key brain functional and biochemical indicators associated with impaired advanced social cognition through an integrated approach encompassing unconscious control, conscious control, cognitive flexibility, problem-solving, and social interaction domains. By incorporating multimodal measures spanning physiological, neural, cognitive, psychological, and behavioral dimensions, we will develop a comprehensive intervention protocol combining course-based brain stimulation and cognitive training. The study will employ a multi-timepoint, multi-level assessment framework to track the enhancement of higher cognitive functions and brain functional recovery in individuals undergoing drug rehabilitation.

Вмешательства

• Устройство Transcranial direct current stimulation
  The participant cohort recruited for this study consists of individuals with substance use disorder (SUD), specifically those addicted to drugs. During the intervention phase, this group will adhere to a strict non-pharmacological intervention protocol, meaning they will not receive any form of pharmacotherapy, neurosurgical intervention, or other neuromodulation-based cognitive interventions, including but not limited to techniques such as transcranial magnetic stimulation (TMS) and transcrania

Первичные конечные точки

• Cortical activation from fNIRS [Срок оценки: From enrollment to the end of treatment at 1 month]
• Cortical functional connectivity from fNIRS [Срок оценки: From enrollment to the end of treatment at 1 month]
• Inter-brain neural synchronization from fNIRS hyperscaning [Срок оценки: From enrollment to the end of treatment at 1 month]
• EEG power [Срок оценки: From enrollment to the end of treatment at 1 month]
• EEG microstate [Срок оценки: From enrollment to the end of treatment at 1 month]
• Functional connectivity from EEG [Срок оценки: From enrollment to the end of treatment at 1 month]
• Realistic presented problem task score [Срок оценки: From enrollment to the end of treatment at 1 month]
• Score on the Group Realistic Problem Solving task [Срок оценки: From enrollment to the end of treatment at 1 month]
• Score on the joint drawing task [Срок оценки: From enrollment to the end of treatment at 1 month]
• Scores on the pattern game task [Срок оценки: From enrollment to the end of treatment at 1 month]

Вторичные конечные точки (8)

• Pupil response from eye-tracking [Срок оценки: From enrollment to the end of treatment at 1 month]
• Average fixation duration from eye-traking [Срок оценки: From enrollment to the end of treatment at 1 month]
• Fixation time percentage from eye-traking [Срок оценки: From enrollment to the end of treatment at 1 month]
• Alternative use task (AUT) score [Срок оценки: From enrollment to the end of treatment at 1 month]
• Score on the Group Alternative Use Task [Срок оценки: From enrollment to the end of treatment at 1 month]
• Cognitive flexibility [Срок оценки: From enrollment to the end of treatment at 1 month]
• Cognitive inhibition [Срок оценки: From enrollment to the end of treatment at 1 month]
• Mind wandering [Срок оценки: From enrollment to the end of treatment at 1 month]

Критерии участия

Критерии включения

• age between 30 and 60 years;
• fulfilling the diagnostic criteria for severe substance use disorder as specified in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders.
• a history of heroin use exceeding ten years, with a daily average intake of at least 0.1 grams.
• abstinence duration of eight months or less, with a positive result of a urine test before entering the rehabilitation center.
• no history of neuromodulation treatments such as tDCS within the past six months.

Критерии исключения

• a history of alcohol dependence, neurological disorders, or other complex psychiatric conditions.
• the presence of intracranial metallic implants or elevated intracranial pressure.
• a history of epilepsy or recent electroencephalogram evidence of epileptiform activity.
• the use of implanted electronic devices, such as pacemakers;.
• scalp hyperalgesia or a tendency toward bleeding.
• severe cardiac conditions.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center — Сиань

Идентификаторы

NCT: NCT06888700 · L20240186 · SFBJYJZXM2023-21-06 · 32471114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗