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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06888700
Enrollment
84
Registered
2025-03-21
Start date
2025-03-19
Completion date
2028-11-17
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Addiction

Keywords

heroin, advanced social cognitive function

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.

Interventions

DEVICETranscranial direct current stimulation

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.

Sponsors

Nanyang Technological University
CollaboratorOTHER
Shaanxi Normal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Realistic presented problem task scoreFrom enrollment to the end of treatment at 1 monthUsed to measure problem-solving ability
Scores on the pattern game taskFrom enrollment to the end of treatment at 1 monthUsed to measure social cooperation and competition
Score on the Group Realistic Problem Solving taskFrom enrollment to the end of treatment at 1 monthUsed to measure collaborative problem-solving ability
Cortical activation from fNIRSFrom enrollment to the end of treatment at 1 month
Cortical functional connectivity from fNIRSFrom enrollment to the end of treatment at 1 month
Inter-brain neural synchronization from fNIRS hyperscaningFrom enrollment to the end of treatment at 1 month
EEG powerFrom enrollment to the end of treatment at 1 month
EEG microstateFrom enrollment to the end of treatment at 1 month
Functional connectivity from EEGFrom enrollment to the end of treatment at 1 month
Score on the joint drawing taskFrom enrollment to the end of treatment at 1 monthUsed to measure interactive collaboration.

Secondary

MeasureTime frameDescription
Average fixation duration from eye-trakingFrom enrollment to the end of treatment at 1 month
Fixation time percentage from eye-trakingFrom enrollment to the end of treatment at 1 month
Alternative use task (AUT) scoreFrom enrollment to the end of treatment at 1 monthUsed to measure problem-solving ability
Score on the Group Alternative Use TaskFrom enrollment to the end of treatment at 1 monthUsed to measure collaborative problem solving ability
Cognitive flexibilityFrom enrollment to the end of treatment at 1 monthAssessed by Wisconsin Card Quest (WCST).
Cognitive inhibitionFrom enrollment to the end of treatment at 1 monthAssessed by stroop task
Mind wanderingFrom enrollment to the end of treatment at 1 monthAssessed by interpolation task
Pupil response from eye-trackingFrom enrollment to the end of treatment at 1 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026