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Enrolling by Invitation

NCT Number: NCT06888700

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

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center

Xi'an, Shaanxi, 710062, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 transcranial direct current stimulation (tDCS). This design aims to ensure the internal validity of the study results and to exclude potential confounding effects of other interventions on neuroplasticity and cognitive function.

Primary outcomes

  1. Cortical activation from fNIRS

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

  2. Cortical functional connectivity from fNIRS

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

  3. Inter-brain neural synchronization from fNIRS hyperscaning

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

  4. EEG power

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

  5. EEG microstate

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

  6. Functional connectivity from EEG

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

  7. Realistic presented problem task score

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

    Used to measure problem-solving ability

  8. 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

  9. Score on the joint drawing task

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

    Used to measure interactive collaboration.

  10. Scores on the pattern game task

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

    Used to measure social cooperation and competition

Secondary outcomes

  1. Pupil response from eye-tracking

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

  2. Average fixation duration from eye-traking

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

  3. Fixation time percentage from eye-traking

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

  4. Alternative use task (AUT) score

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

    Used to measure problem-solving ability

  5. 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 ability

  6. Cognitive flexibility

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

    Assessed by Wisconsin Card Quest (WCST).

  7. Cognitive inhibition

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

    Assessed by stroop task

  8. Mind wandering

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

    Assessed by interpolation task

Sponsors and collaborators

Lead sponsor

Shaanxi Normal University

Other

Collaborators

  • Nanyang Technological University

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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