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

NCT06888700 | Enrolling By Invitation DMC

• 3 other identifiers: L20240186SFBJYJZXM2023-21-0632471114
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Addiction

Keywords

heroin; advanced social cognitive function

Outcome Measures

Primary Outcomes (10)

• 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

• EEG power

  From enrollment to the end of treatment at 1 month

• EEG microstate

  From enrollment to the end of treatment at 1 month

• Functional connectivity from EEG

  From enrollment to the end of treatment at 1 month

• Realistic presented problem task score

  Used to measure problem-solving ability

  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

• Score on the joint drawing task

  Used to measure interactive collaboration.

  From enrollment to the end of treatment at 1 month

• Scores on the pattern game task

  Used to measure social cooperation and competition

  From enrollment to the end of treatment at 1 month

Secondary Outcomes (8)

• Pupil response from eye-tracking

  From enrollment to the end of treatment at 1 month

• 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

• Alternative use task (AUT) score

  From enrollment to the end of treatment at 1 month

• Score on the Group Alternative Use 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 anode was positioned over the rTPJ (P6), with the cathode placed on the left sub-occipital region. 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

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 anode was positioned over the rTPJ (P6), with the cathode placed on the left sub-occipital region.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 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.

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

• Shaanxi Normal University: 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: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory Manager

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 21, 2025
• Study Start: March 19, 2025
• Primary Completion: April 18, 2025
• Study Completion (Estimated): November 17, 2028
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)