Closed-loop tACS Modulation for the Core Clinical Features of Drug Addiction

NCT06454474 | Completed

• 1 other identifier: MZhao-016
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes the effect of closed-loop tACS based on brain states

Conditions

Amphetamine Use Disorders

Outcome Measures

Primary Outcomes (1)

• Change of Craving assessed by Visual Analog Scale (VAS)

  The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale (VAS), where individuals rated their cravings on a scale from 0 to 10, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation.

  through study completion, an average of 1 month

Secondary Outcomes (2)

• Stop-signal task

  through study completion, an average of 1 monoth

• Drug Use

  through study completion, an average of 1 month

Study Arms (1)

Closed-loop tACS stimulation based on addiction-induced states

EXPERIMENTAL

In the initial phase of this study, participants will be subjected to individual closed-loop tACS interventions for ten-days intervals. Concurrently, they will be exposed to MA-related cue paradigms to induce brain addiction states, while scalp EEG signals are collected. Stimulation will be initiated only upon identifying specific neural signals associated with MA cues.

Device: Closed-loop tACS stimulation based on addiction-induced states

Interventions

Closed-loop tACS stimulation based on addiction-induced states DEVICE

We conducted a longitudinal controlled study of closed-loop tACS interventions among MA dependents.This involved implementing interventions based on addiction-induced states.

Closed-loop tACS stimulation based on addiction-induced states

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged between 18 and 45 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
• Meet the diagnostic criteria set forth by the DSM-V concerning the severity of amphetamine-type substance addiction.
• A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
• Consent to actively cooperate in the completion of subsequent follow-up assessments.

You may not qualify if:

• Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
• A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
• Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
• Severe organic diseases that might compromise study participation. Contraindications to tACS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai, Shanghai, China, 200000, China

Location

Study Officials

• MIn Zhao

  Shanghai Mental Health Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)