Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SFBJYJZXM2023-21-06 | Other Grant/Funding Number | Ministry of Justice in China | |
| 32471114 | Other Grant/Funding Number | The National Natural Science Foundation of China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nanyang Technological University | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center | Xi'an | Shaanxi | 710062 | China |
This study is a government-collaborative project involving sensitive personal information of a vulnerable population, and as such, it is imperative to adhere to strict confidentiality protocols. All data collected will be handled in compliance with ethical guidelines and legal requirements to ensure the protection of participants' privacy.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Scores on the pattern game task | Used to measure social cooperation and competition | 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 | Used to measure problem-solving ability | From enrollment to the end of treatment at 1 month |
| Score on the Group Alternative Use Task | Used to measure collaborative problem solving ability | From enrollment to the end of treatment at 1 month |
| Cognitive flexibility | Assessed by Wisconsin Card Quest (WCST). | From enrollment to the end of treatment at 1 month |
| Cognitive inhibition | Assessed by stroop task | From enrollment to the end of treatment at 1 month |
| Mind wandering | Assessed by interpolation task | From enrollment to the end of treatment at 1 month |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |