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Completed

NCT Number: NCT06917534

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

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.

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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 drug addiction 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. 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

  2. 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

  3. Cortical activation from fNIRS

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

  4. Cortical functional connectivity from fNIRS

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

  5. Inter-brain neural synchronization from fNIRS hyperscaning

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

  6. Pupil response from eye-tracking

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

  7. 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

  8. 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

Secondary outcomes

  1. Average fixation duration from eye-traking

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

  2. Fixation time percentage from eye-traking

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

  3. Score on the joint drawing task

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

    Used to measure collaborative problem-solving from the perspective of social interaction.

  4. Score on the Chain Free Association Task

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

    Used to measure remote associative ability.

  5. Score on the Verbal Fluency Task

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

    Used to measure remote association ability

  6. Score on the Divergent Association Task

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

    used to measure the divergent Association ability

  7. Score on the Wsiconsin Card Sorting Test (WCST)

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

    Used to measure cognitive flexibility.

Sponsors and collaborators

Lead sponsor

Yifan Wang

Other

Collaborators

  • Nanyang Technological University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2025
Registry last updated
Apr 8, 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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