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临床试验/NCT06917534
NCT06917534已完成不适用

The Cognitive Neural Mechanisms and Neuroregulatory Interventions of Realistic Creative Problem-solving Under the Effects of Drug Addiction

Yifan Wang1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Score on the Group Alternative Use Task

研究概览

简要总结

Drug addiction persists as a significant global social concern with a negative impact on social harmony and stability that cannot be ignored. After returning to society, individuals with drug addiction often suffer from impaired creative problem-solving abilities and difficulties in interpersonal cooperation. The difficulties in survival stress and the sense of helplessness triggered by these factors are important reasons that lead them to seek drugs repeatedly and even to commit criminal behaviors. Therefore, enhancing creative realistic problem-solving abilities emerges as a pivotal pathway for drug addicts to facilitate rehabilitation from drug addiction and achieve societal adaptation. The project emphasizes both individual and collaborative creative solution generation for realistic problem solving. The abnormal cognitive neural mechanisms and interpersonal neural mechanisms will be systematically explored by using multiple cognitive and neuroimaging methods, such as functional near-infrared spectroscopy (fNIRS), electroencephalography (EEG), and eye-tracking. From the cognitive-behavioral-brain level, a comprehensive neurophysiological multimodal predictive model of how drug addiction affects creative realistic problem-solving will be constructed by multi-level data fitting modeling. Building upon this research foundation, The investigators will further implement single and repeated sessions of transcranial direct current stimulation (tDCS) targeting damaged brain regions for the intervention of individual and collaborative problem-solving ability under the effect of drug addiction. The indicators of brain, cognition, and behavior will be tracked at multiple time points.

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 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

Arm Description: 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 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)

结局指标

主要结局

Score on the Group Alternative Use Task

时间窗: From enrollment to the end of treatment at 1 month

Used to measure collaborative problem-solving

Score on the Realistic Presented Problem Task

时间窗: From enrollment to the end of treatment at 1 month

Used to measure problem-solving ability individual creative problem-solving

Score on the Group Realistic Problem Solving Task

时间窗: From enrollment to the end of treatment at 1 month

Used to measure collaborative problem-solving ability

Cortical activation from fNIRS

时间窗: From enrollment to the end of treatment at 1 month

Cortical functional connectivity from fNIRS

时间窗: From enrollment to the end of treatment at 1 month

Inter-brain neural synchronization from fNIRS hyperscaning

时间窗: From enrollment to the end of treatment at 1 month

Pupil response from eye-tracking

时间窗: From enrollment to the end of treatment at 1 month

Score on the Alternative Use Task

时间窗: From enrollment to the end of treatment at 1 month

Used to measure the individual problem-solving ability

次要结局

  • Average fixation duration from eye-traking(From enrollment to the end of treatment at 1 month)
  • Fixation time percentage from eye-traking(From enrollment to the end of treatment at 1 month)
  • Score on the joint drawing task(From enrollment to the end of treatment at 1 month)
  • Score on the Chain Free Association Task(From enrollment to the end of treatment at 1 month)
  • Score on the Verbal Fluency Task(From enrollment to the end of treatment at 1 month)
  • Score on the Divergent Association Task(From enrollment to the end of treatment at 1 month)
  • Score on the Wsiconsin Card Sorting Test (WCST)(From enrollment to the end of treatment at 1 month)

研究者

发起方
Yifan Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yifan Wang

Laboratory Manager

Shaanxi Normal University

研究点 (1)

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