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

Shanghai Mental Health Center

Status: Not yet enrolling

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

Treatments: Device: Closed-loop TMS; Device: Random TMS; Device: Conventional TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT07154160

MZhao-021

Details and patient eligibility

About

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups

Closed-loop Group

Experimental group

Description:

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.

Treatment:

Device: Closed-loop TMS

Conventional TMS Group

Active Comparator group

Description:

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.

Treatment:

Device: Conventional TMS

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Device: Random TMS