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

NCT07154160 | Not Yet Recruiting

• 1 other identifier: MZhao-021
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Use Disorder; Substance Use Disorder; Cue-reactivity; Craving

Outcome Measures

Primary Outcomes (1)

• Cue-Induced Neural Reactivity During Before and After Stimulation

  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).

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

Secondary Outcomes (2)

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

  Before and within 30 minutes after stimulation

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

  Before and within 30 minutes after stimulation

Study Arms (3)

Closed-loop Group

EXPERIMENTAL

Participants in this arm will receive closed-loop TMS. Before stimulation: The researchers measure the participant's Resting Motor Threshold (RMT) and assess their craving using VAS before and after view a methamphetamine-related video. The participants complete SST. During the stimulation phase, participants will: First undergo a training phase, during which EEG will be recorded while they perform a cue-reactivity task to identify neural signatures and calculate stimulation thresholds. Then perform the cue-reactivity task again, and real-time EEG features will be used to trigger TMS in a closed-loop mode. After the stimulation, participants will: The researchers again assess their craving using VAS before and after viewing the video. The participants again complete the SST. The researchers record adverse reactions and adverse events, and evaluate the blinding effect, through a Blinding Assessment Questionnaire.

Device: Closed-loop TMS

Conventional TMS Group

ACTIVE COMPARATOR

Participants in this arm will receive conventional TMS. Before stimulation: The researchers measure the participant's RMT and assess their craving using VAS before and after view a methamphetamine-related video. The participants complete SST. During the stimulation phase, participants will: First undergo a training phase, during which EEG will be recorded while they perform a cue-reactivity task to identify neural signatures and calculate stimulation thresholds. Then receive a TMS treatment delivered at a conventional iTBS protocol, and perform perform the cue-reactivity task again afterwards. After the stimulation, participants will: The researchers again assess their craving using VAS before and after viewing a methamphetamine-related video. The participants again complete the SST. The researchers record adverse reactions and adverse events, and evaluate the blinding effect, through a Blinding Assessment Questionnaire.

Device: Conventional TMS

Sham Group

SHAM COMPARATOR

Participants in this arm will receive random TMS. Before stimulation: The researchers measure the participant's Resting Motor Threshold (RMT) and assess their craving using VAS before and after view a methamphetamine-related video. The participants complete SST. During the stimulation phase, participants will: First undergo a training phase, during which EEG will be recorded while they perform a cue-reactivity task to identify neural signatures and calculate stimulation thresholds. Then perform the cue-reactivity task again, TMS will be triggered by a random sequence unrelated to real-time EEG features. After the stimulation, participants will: The researchers again assess their craving using VAS before and after viewing a methamphetamine-related video. The participants again complete the SST. The researchers record adverse reactions and adverse events, and evaluate the blinding effect, through a Blinding Assessment Questionnaire.

Device: Random TMS

Interventions

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.

Also known as: EEG-TMS, Closed-loop TBS, EEG triggered TMS

Closed-loop Group

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.

Conventional TMS Group

Random TMS DEVICE

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

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center, 200030

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Min Zhao, PhD

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Min Zhao, PhD

CONTACT

+86 18017311005; drminzhao@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: August 1, 2026
• Primary Completion: September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

CN (1)