NCT06165198

Brief Summary

Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes closed-loop tACS based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop tACS methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

November 19, 2025

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 16, 2023

Last Update Submit

November 16, 2025

Conditions

Amphetamine Use Disorders

Keywords

individualized therapyclosed-loopAmphetamine-type stimulantstACS

Outcome Measures

Primary Outcomes (1)

  • Stop-signal task

    The stop-signal task can indicate executive control capabilities by measuring Stop-signal reaction time, Stop-signal delays, Go-task reaction time, and Success and failure inhibition rates.

    through study completion, an average of 1 month

Secondary Outcomes (1)

  • Changes of electroencephalogram power spectrum

    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 at varying frequencies for one-week 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, aiming to ascertain the optimal frequency for single-session closed-loop tACS stimulation that could elicit individual neurological responses. Subsequently, we will embark on a longitudinal closed-loop tACS intervention control study for MA dependents at one-week intervals, which involves addiction-induced closed-loop tACS stimulation, random time-point stimulation, and traditional continuous stimulation, to rectify potential sequence effects and delineate the disparities in neurological and behavioral impacts between discrete and continuous stimulations based on brain states.

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

Interventions

Closed-loop tACS stimulation based on addiction-induced statesDEVICE

We conducted a longitudinal controlled study of closed-loop tACS interventions among MA dependents.This involved implementing interventions based on addiction-induced states through closed-loop tACS stimulation, randomized time-point stimulation, and traditional continuous stimulation.

Closed-loop tACS stimulation based on addiction-induced states

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

Location

Study Officials

  • MIn Zhao, PhD

    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

September 16, 2023

First Posted

December 11, 2023

Study Start

September 25, 2023

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

November 19, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)