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

Shaanxi Normal University1 个研究点分布在 1 个国家目标入组 84 人开始时间: 2025年3月19日最近更新: 2025年3月21日

适应症

干预措施

试验速览

阶段: 不适用
状态: Enrolling By Invitation
发起方
入组人数: 84
试验地点: 1
主要终点: Realistic presented problem task score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 30 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

Active group

Active Comparator

The study was sham-controlled, randomized, and double-blind. Participants with HUD were randomly assigned to either the active or sham groups. The DC-STIMULATOR PLUS (neuroConn, Germany) was used to deliver stimulation via saline-soaked sponge electrodes (25 cm², 5×5 cm, 1.5 mA). The anode was positioned over the rTPJ (P6), with the cathode placed on the left sub-occipital region. The stimulation in the active group lasted for 20 min with a 30-s fade-in and a 30-s fade-out. They received five stimulation sessions within one week, with a minimum interval of 24 hours between each session. The tDCS sensitivity questionnaire was used to assess blinding validity.

干预措施: Transcranial direct current stimulation (Device)

Sham group

Sham Comparator

The study was sham-controlled, randomized, and double-blind. Participants with HUD were randomly assigned to either the active or sham groups. The DC-STIMULATOR PLUS (neuroConn, Germany) was used to deliver stimulation via saline-soaked sponge electrodes (25 cm², 5×5 cm, 1.5 mA). The anode was positioned over the rTPJ (P6), with the cathode placed on the left sub-occipital region.The stimulation in the sham group was set up as a stimulation cycle of 30s fade-in and 30s fade-out, followed by no current stimulation. They received five stimulation sessions within one week, with a minimum interval of 24 hours between each session. The tDCS sensitivity questionnaire was used to assess blinding validity.

干预措施: Transcranial direct current stimulation (Device)