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

Shaanxi Normal University

Status: Invitation-only

Conditions: Drug Addiction

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06888700

32471114 (Other Grant/Funding Number)

SFBJYJZXM2023-21-06 (Other Grant/Funding Number)

L20240186

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

Active group

Active Comparator group

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 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.

Treatment:

Device: Transcranial direct current stimulation

Sham group

Sham Comparator group

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 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.

Treatment:

Device: Transcranial direct current stimulation