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

A Pilot Single-Arm Study of Closed-Loop TBS Theta-Burst Stimulation Targeting the Right Parietal-Occipital Cortex for Core Clinical Features of Methamphetamine Use Disorder

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07775807
Enrollment
5
Registered
2026-08-20
Start date
2026-08-01
Completion date
2026-12-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craving, Cue-reactivity, Methamphetamine Use Disorder, Substance Use Disorder

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.

Interventions

DEVICEClosed-loop Theta-Burst Stimulation (TBS) Targeting rPO

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.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cue-Induced Neural Reactivity During Before and After StimulationDuring cue-reactivity task in training and stimulation phases of each session.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.

Secondary

MeasureTime frameDescription
Change in Cue-Induced Craving Measured by Visual Analog Scale (VAS)Before and within 30 minutes after stimulationParticipants 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).
Change in Inhibitory Control Assessed by Stop Signal Task (SST)Before and within 30 minutes after stimulationParticipants 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.

Countries

China

Contacts

CONTACTMin Zhao, PhD
drminzhao@smhc.org.cn+86 18017311005

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026