Closed-loop TBS Targeting rPO for the Core Clinical Features of the Methamphetamine Use Disorder

NCT07775807 | Not Yet Recruiting

• 1 other identifier: MZhao-030
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether closed-loop theta-burst stimulation (TBS) targeting the right parietal-occipital cortex (rPO) 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 rPO-TBS significantly reduce cue-reactivity, as measured by a Visual Analog Scale (VAS) and a cue-reactivity task? Does closed-loop stimulation enhance cognitive control, assessed by performance on the Stop Signal Task (SST)? Researchers will administer closed loop TBS to determine whether it can improve the core symptoms of MUD. Participants will: Complete a single closed-loop sessions. Receive theta-burst stimulation targeting the right parietal-occipital cortex while complete the cue-reactivity task. Undergo cue-reactivity assessment using a Visual Analog Scale (VAS) and complete the Stop Signal Task (SST) before and after the 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 TBS). 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.

  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 (1)

Closed-loop Group

EXPERIMENTAL

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 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: Closed-loop Theta-Burst Stimulation (TBS) Targeting rPO

Interventions

Closed-loop Theta-Burst Stimulation (TBS) Targeting rPO DEVICE

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

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

Closed-loop 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

Central Study Contacts

Min Zhao, PhD

CONTACT

+86 18017311005; drminzhao@smhc.org.cn

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: August 16, 2026
• First Posted: August 20, 2026
• Study Start: August 1, 2026
• Primary Completion: September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Locations

CN (1)