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

N/ANot Yet RecruitingNCT07154160

Shanghai Mental Health Center21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Methamphetamine Use Disorder Substance Use Disorder

Interventions

Closed-loop TMSDEVICE

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.

Conventional TMSDEVICE

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 TMSDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

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

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.

Time frame: Before and within 30 minutes after stimulation

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

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.