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

NCT06917534 | Completed DMC

• 2 other identifiers: L2023012232471114
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Addiction

Keywords

heroin; creative problem solving; divergent thinking; group problem solving

Outcome Measures

Primary Outcomes (8)

• Score on the Realistic Presented Problem Task

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

  From enrollment to the end of treatment at 1 month

• Score on the Group Realistic Problem Solving Task

  Used to measure collaborative problem-solving ability

  From enrollment to the end of treatment at 1 month

• Cortical activation from fNIRS

  From enrollment to the end of treatment at 1 month

• Cortical functional connectivity from fNIRS

  From enrollment to the end of treatment at 1 month

• Inter-brain neural synchronization from fNIRS hyperscaning

  From enrollment to the end of treatment at 1 month

• Pupil response from eye-tracking

  From enrollment to the end of treatment at 1 month

• Score on the Alternative Use Task

  Used to measure the individual problem-solving ability

  From enrollment to the end of treatment at 1 month

• Score on the Group Alternative Use Task

  Used to measure collaborative problem-solving

  From enrollment to the end of treatment at 1 month

Secondary Outcomes (7)

• 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

Study Arms (2)

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.

Device: Transcranial direct current stimulation

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.

Device: Transcranial direct current stimulation

Interventions

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.

Active group; Sham group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yifan Wang: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center

Xi'an, Shaanxi, 710062, China

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Laboratory Manager

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 8, 2025
• Study Start: November 23, 2023
• Primary Completion: May 18, 2024
• Study Completion: August 15, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)