Methamphetamine Use DisorderNCT07775807
Closed-loop TBS Targeting rPO for the Core Clinical Features of the Methamphetamine Use Disorder
A study testing Closed-loop Theta-Burst Stimulation (TBS) Targeting rPO in people with Methamphetamine Use Disorder and Substance Use Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Use Disorder, Substance Use Disorder, Cue-reactivity
- What is being tested?
- Closed-loop Theta-Burst Stimulation (TBS) Targeting rPO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center, 200030
Shanghai, Shanghai Municipality, 200000
Min Zhao, PhD, 18017311005, drminzhao@smhc.org.cn
About this study
Official 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
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:
Read more
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.
- Being tested
- Closed-loop Theta-Burst Stimulation (TBS) Targeting rPO
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop Theta-Burst Stimulation (TBS) Targeting rPODevice
Also called EEG-TMS, Closed-loop rPO-TBS
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.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop Group | Experimental | 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 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. Receives: Device: Closed-loop Theta-Burst Stimulation (TBS) Targeting rPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During cue-reactivity task in training and stimulation phases of each session.
Secondary outcomes (2)
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).
Measured: 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.
Measured: Before and within 30 minutes after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775807
- Sponsor's protocol ID
- MZhao-030
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No