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Clinical Trials/NCT06917534
NCT06917534CompletedNot Applicable

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

Yifan Wang1 site in 1 country80 target enrollmentStarted: November 23, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Score on the Group Alternative Use Task

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: 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.

Intervention: Transcranial direct current stimulation (Device)

Outcomes

Primary Outcomes

Score on the Group Alternative Use Task

Time Frame: From enrollment to the end of treatment at 1 month

Used to measure collaborative problem-solving

Score on the Realistic Presented Problem Task

Time Frame: 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

Time Frame: From enrollment to the end of treatment at 1 month

Used to measure collaborative problem-solving ability

Cortical activation from fNIRS

Time Frame: From enrollment to the end of treatment at 1 month

Cortical functional connectivity from fNIRS

Time Frame: From enrollment to the end of treatment at 1 month

Inter-brain neural synchronization from fNIRS hyperscaning

Time Frame: From enrollment to the end of treatment at 1 month

Pupil response from eye-tracking

Time Frame: From enrollment to the end of treatment at 1 month

Score on the Alternative Use Task

Time Frame: From enrollment to the end of treatment at 1 month

Used to measure the individual problem-solving ability

Secondary Outcomes

  • 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)

Investigators

Sponsor
Yifan Wang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Yifan Wang

Laboratory Manager

Shaanxi Normal University

Study Sites (1)

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