CClinicalTrials.gg
CompletedNCT06454474Updated Aug 11, 2026

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

An interventional study of Closed-loop tACS stimulation based on addiction-induced states in Amphetamine Use Disorders, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed description

Methamphetamine use disorder (MUD) addiction represents a severe public health concern. Individuals addicted to methamphetamine exhibit intense cravings and physiological reactions when exposed to addiction-related cues, a phenomenon termed "cue reactivity." Cue reactivity is a critical factor in the development and persistence of addiction. Impairments in inhibitory control are considered a significant factor contributing to the emergence of cue reactivity. Conventional pharmacological and physical interventions suffer from low efficiency and high effect variance. Closed-loop physical interventions, which adjust stimulation parameters in real-time based on brain state, are an innovative approach with the potential to enhance the precision and efficiency of treatments. Closed-loop interventions based on transcranial alternating current stimulation (tACS) hold promise as a novel therapeutic method for treating methamphetamine addiction. This study aims to develop and evaluate the effect of closed-loop tACS on cue reactivity and inhibition control function in MUD. Therefore, the investigators intend to employ the non-invasive tACS technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.

02

Conditions studied

  • Amphetamine Use Disorders
03

In context

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 9 years of education or are capable of effectively cooperating in questionnaire evaluations.

Meet the diagnostic criteria set forth by the DSM-5 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 of at least once per week.

Consent to actively cooperate in the completion of subsequent follow-up assessments.

Exclusion criteria

Exclusion Criteria:

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, include a history of epileptic seizures or the presence of metallic implants in proximity to the head.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Closed-loop tACS stimulation based on addiction-induced states

    In the initial phase of this study, participants will receive individualized closed-loop tACS interventions once daily for five consecutive days. Concurrently, they will be exposed to MA-related cue paradigms to induce cue-reactivity 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

  • DeviceClosed-loop tACS stimulation based on addiction-induced states

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

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale for craving (VAS-Craving)

    The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale for craving (VAS-Craving), where individuals rated their cravings on a scale from 0 to 100, 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.

    Time frame: through study completion, an average of 5 days

Secondary outcomes

  1. Stop-signal task

    The stop-signal task can indicate executive control capabilities by measuring Stop-signal reaction time (SSRT), Stop-signal delays (SSD), Go-task reaction time (RT), and Success and failure inhibition rates. A lower SSRT value indicates better inhibitory control.

    Time frame: through study completion, an average of 5 days

  2. Obsessive Compulsive Drug Use Scale (OCDUS)

    The Obsessive Compulsive Drug Use Scale (OCDUS) measures the overall craving level within a period from a multidimensional perspective. The scale consists of 13 items and uses a five-point scoring system, with each item scored on a scale of 1 to 5. The higher the total score, the greater the level of craving.

    Time frame: through study completion, an average of 5 days

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Study locations

1 site
  • Shanghai Mental Health Center
    Shanghai, Shanghai, Shanghai, China, 200000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06454474
Lead sponsor
Shanghai Mental Health Center
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
Jun 30, 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Aug 11, 2026

Study contacts

MIn Zhao
study chair · Shanghai Mental Health Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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