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NCT Number: NCT07154160

Closed-loop TMS for the Core Clinical Features of the Methamphetamine Use Disorder

The goal of this clinical trial is to evaluate whether closed-loop transcranial magnetic stimulation (TMS) can improve core clinical symptoms in individuals with methamphetamine use disorder (MUD), such as cue-reactivity and impaired inhibitory control.

The main questions it aims to answer are:

Can closed-loop TMS significantly reduce cue-reactivity, as measured by a Visual Analog Scale (VAS) and cue-reactivity task, compared to a conventional treatment protocol and random TMS ? Does closed-loop stimulation enhance cognitive control, assessed by performance on the Stop Signal Task (SST), more effectively than the other stimulation modes? Researchers will compare closed-loop, conventional, and random TMS conditions to determine whether closed-loop yields superior symptom improvement.

Participants will:

Be randomly assigned to one of the three stimulation group (closed-loop, conventional and random) according to a pre generated random number table, and receive the corresponding stimulation session.

Undergo cue-reactivity assessment using VAS and cue-reactivity task, and complete the SST before and after each stimulation session.

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Key information

Conditions

Methamphetamine Use Disorder Chemically-Induced Disorders Craving Cue-reactivity Mental Disorders Substance Use Disorder Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center, 200030

Shanghai, Shanghai Municipality, 200000, China

Location contact

Min Zhao, PhD

CONTACT

[email protected]

18017311005

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 18 years old or older, ....with at least 9 years of education (junior high school or above) or able to fully understand the task.

Meets DSM-5 for mild/severe amphetamine-type substance use disorder. History of amphetamine-type substance use for no less than 1 year, with use at least once per week.

Has not received pharmacological treatment for substance use.

Exclusion criteria

Presence of any organic disease, or diagnosis of any other psychiatric disorder according to DSM-5 (e.g., bipolar disorder, major depression disorder).

Contraindications to TMS, as assessed by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS).

Inability to complete assessments, treatment procedures, or follow-up due to cognitive or behavioral limitations.

Treatment and study plan

Closed-loop TMS

Device

Participants receive theta burst stimulation (TBS), triggered by real-time EEG signals recorded during a cue-reactivity task. This closed-loop protocol aims to deliver stimulation precisely during neural states associated with cue-induced craving.

Other names: EEG-TMS, Closed-loop TBS, EEG triggered TMS

Conventional TMS

Device

Participants receive TBS, delivered at a standard iTBS protocol (3-pulse 50-Hz bursts given at every 200 ms (i.e. at 5 Hz), 2s on and 8s off, with 1200 pulses in total), without EEG or task engagement.

Random TMS

Device

Participants receive TBS, triggered by a random sequence unrelated to real-time EEG features.

Primary outcomes

  1. Cue-Induced Neural Reactivity During Before and After Stimulation

    Time frame: During cue-reactivity task in training and stimulation phases of each session.

    EEG signals will be recorded while participants perform a cue-reactivity task during both the training phase (no stimulation) and the stimulation phase (with TMS). The primary outcome will be changes in cue-induced neural reactivity, defined by EEG features such as event-related potentials (ERPs) and power spectral density (e.g., theta or alpha power) in response to methamphetamine-related cues. Comparisons will be made across stimulation conditions (closed-loop, conventional, random) and phases (pre- vs. during stimulation).

Secondary outcomes

  1. Change in Cue-Induced Craving Measured by Visual Analog Scale (VAS)

    Time frame: Before and within 30 minutes after stimulation

    Participants will rate their craving levels after viewing methamphetamine-related videos using a Visual Analog Scale (VAS), ranging from 0 (no craving) to 100 (maximum craving). Craving scores will be recorded immediately before and after each stimulation session under all three stimulation conditions.

  2. Change in Inhibitory Control Assessed by Stop Signal Task (SST)

    Time frame: Before and within 30 minutes after stimulation

    Participants will complete the Stop Signal Task (SST) before and after each stimulation session. Measures such as Stop Signal Reaction Time (SSRT) and accuracy will be used to assess changes in inhibitory control performance across different stimulation conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Zhao, PhD

CONTACT

[email protected]

+86 18017311005

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

A Single-blind, Randomized, Parallel Study of Closed-loop, Conventional and Random TMS for Core Clinical Features of Methamphetamine Use Disorder.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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