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

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

Interventions

DEVICE

Closed-loop TMS

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.

DEVICE

Conventional TMS

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.

DEVICE

Random TMS

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

Sponsors & Collaborators

• Shanghai Mental Health Center

  lead OTHER

Principal Investigators

• Min Zhao, PhD · Shanghai Mental Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• China

Study Locations