Clinical trial NCT06888700: Project on tDCS Intervention to Enhance Advanced Social Cognitive Functions in Drug Rehabilitation Individuals
Official title: Project on tDCS Intervention to Enhance Advanced Social Cognitive Functions in Drug Rehabilitation Individuals
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Drug Addiction
Keywords: heroin
advanced social cognitive function
Lead sponsor: Shaanxi Normal University
Sponsor class: OTHER
Collaborators: name: Nanyang Technological University
First posted: 2025-03-21
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cortical activation from fNIRS
timeFrame: From enrollment to the end of treatment at 1 month
measure: Cortical functional connectivity from fNIRS
timeFrame: From enrollment to the end of treatment at 1 month
measure: Inter-brain neural synchronization from fNIRS hyperscaning
timeFrame: From enrollment to the end of treatment at 1 month
measure: EEG power
timeFrame: From enrollment to the end of treatment at 1 month
measure: EEG microstate
timeFrame: From enrollment to the end of treatment at 1 month
measure: Functional connectivity from EEG
timeFrame: From enrollment to the end of treatment at 1 month
measure: Realistic presented problem task score
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Group Realistic Problem Solving task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the joint drawing task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Scores on the pattern game task
timeFrame: From enrollment to the end of treatment at 1 month
Secondary outcomes:
measure: Pupil response from eye-tracking
timeFrame: From enrollment to the end of treatment at 1 month
measure: Average fixation duration from eye-traking
timeFrame: From enrollment to the end of treatment at 1 month
measure: Fixation time percentage from eye-traking
timeFrame: From enrollment to the end of treatment at 1 month
measure: Alternative use task (AUT) score
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Group Alternative Use Task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Cognitive flexibility
timeFrame: From enrollment to the end of treatment at 1 month
measure: Cognitive inhibition
timeFrame: From enrollment to the end of treatment at 1 month
measure: Mind wandering
timeFrame: From enrollment to the end of treatment at 1 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center
state: Shaanxi
Study officials:
References: