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The Cognitive Neural Mechanisms and Neuroregulatory Interventions of Realistic Creative Problem-solving Under the Effects of Drug Addiction

Status

Completed

Conditions

Drug Addiction

Treatments

Device: Transcranial direct current stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06917534
L20230122
32471114 (Other Grant/Funding Number)

Details and patient eligibility

About

Drug addiction persists as a significant global social concern with a negative impact on social harmony and stability that cannot be ignored. After returning to society, individuals with drug addiction often suffer from impaired creative problem-solving abilities and difficulties in interpersonal cooperation. The difficulties in survival stress and the sense of helplessness triggered by these factors are important reasons that lead them to seek drugs repeatedly and even to commit criminal behaviors. Therefore, enhancing creative realistic problem-solving abilities emerges as a pivotal pathway for drug addicts to facilitate rehabilitation from drug addiction and achieve societal adaptation. The project emphasizes both individual and collaborative creative solution generation for realistic problem solving. The abnormal cognitive neural mechanisms and interpersonal neural mechanisms will be systematically explored by using multiple cognitive and neuroimaging methods, such as functional near-infrared spectroscopy (fNIRS), electroencephalography (EEG), and eye-tracking. From the cognitive-behavioral-brain level, a comprehensive neurophysiological multimodal predictive model of how drug addiction affects creative realistic problem-solving will be constructed by multi-level data fitting modeling. Building upon this research foundation, The investigators will further implement single and repeated sessions of transcranial direct current stimulation (tDCS) targeting damaged brain regions for the intervention of individual and collaborative problem-solving ability under the effect of drug addiction. The indicators of brain, cognition, and behavior will be tracked at multiple time points.

Enrollment

80 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

80 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 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:
Arm 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 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

Trial contacts and locations

1

There are currently no registered sites for this trial.

Timeline

Last updated: Apr 08, 2025

Start date

Nov 23, 2023 • 1 year and 5 months ago

End date

May 18, 2024 • 11 months ago

Today

Apr 30, 2025

Sponsor of this trial

Lead Sponsor

Collaborating Sponsor

N

Nanyang Technological University

Data sourced from clinicaltrials.gov