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

N/ANot Yet RecruitingNCT07775807

Shanghai Mental Health Center5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Methamphetamine Use Disorder Substance Use Disorder Cue-reactivity

Interventions

Closed-loop Theta-Burst Stimulation (TBS) Targeting rPODEVICE

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.

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 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.

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).

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.