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Enrolling by invitation NCT06888700

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

No phase Interventional Drug Addiction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial direct current stimulation.
Who it may be relevant to
Registry conditions: Drug Addiction. Basic parameters: 30 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Transcranial 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 transcrania

Primary outcome measures

  • Cortical activation from fNIRS [Time frame: From enrollment to the end of treatment at 1 month]
  • Cortical functional connectivity from fNIRS [Time frame: From enrollment to the end of treatment at 1 month]
  • Inter-brain neural synchronization from fNIRS hyperscaning [Time frame: From enrollment to the end of treatment at 1 month]
  • EEG power [Time frame: From enrollment to the end of treatment at 1 month]
  • EEG microstate [Time frame: From enrollment to the end of treatment at 1 month]
  • Functional connectivity from EEG [Time frame: From enrollment to the end of treatment at 1 month]
  • Realistic presented problem task score [Time frame: From enrollment to the end of treatment at 1 month]
  • Score on the Group Realistic Problem Solving task [Time frame: From enrollment to the end of treatment at 1 month]
  • Score on the joint drawing task [Time frame: From enrollment to the end of treatment at 1 month]
  • Scores on the pattern game task [Time frame: From enrollment to the end of treatment at 1 month]
Secondary outcome measures (8)
  • Pupil response from eye-tracking [Time frame: From enrollment to the end of treatment at 1 month]
  • Average fixation duration from eye-traking [Time frame: From enrollment to the end of treatment at 1 month]
  • Fixation time percentage from eye-traking [Time frame: From enrollment to the end of treatment at 1 month]
  • Alternative use task (AUT) score [Time frame: From enrollment to the end of treatment at 1 month]
  • Score on the Group Alternative Use Task [Time frame: From enrollment to the end of treatment at 1 month]
  • Cognitive flexibility [Time frame: From enrollment to the end of treatment at 1 month]
  • Cognitive inhibition [Time frame: From enrollment to the end of treatment at 1 month]
  • Mind wandering [Time frame: From enrollment to the end of treatment at 1 month]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center — Xi'an

Identifiers

NCT: NCT06888700 · L20240186 · SFBJYJZXM2023-21-06 · 32471114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗