Shanghai Mental Health Center, 200030
Shanghai, Shanghai Municipality, 200000, China
Not yet recruiting
NCT Number: NCT07775807
Closed-loop TBS Targeting rPO for the Core Clinical Features of the Methamphetamine Use Disorder
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.
Not yet recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Closed-loop Theta-Burst Stimulation (TBS) Targeting rPO
DeviceParticipants 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.
Other names: EEG-TMS, Closed-loop rPO-TBS
Primary outcomes
-
Cue-Induced Neural Reactivity During Before and After Stimulation
Time frame: During 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 outcomes
-
Change in Cue-Induced Craving Measured by Visual Analog Scale (VAS)
Time frame: Before and within 30 minutes after stimulation
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).
-
Change in Inhibitory Control Assessed by Stop Signal Task (SST)
Time frame: Before and within 30 minutes after stimulation
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shanghai Mental Health Center
Other
Registry information
Official study title
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
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 20, 2026
- Registry last updated
- Aug 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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