Methamphetamine Use DisorderNCT07775807
Closed-loop TBS Targeting rPO for the Core Clinical Features of 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
- 5 Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (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.
China1 site
Shanghai Mental Health Center, 200030
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Pilot Single-Arm Study of Closed-Loop Theta-Burst Stimulation (TBS) Targeting the Right Parietal-Occipital Cortex (rPO) 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 session. Receive theta-burst stimulation targeting the right parietal-occipital cortex while completing 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 viewing 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 Electroencephalography (EEG) features will be used to trigger Transcranial Magnetic Stimulation (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 power spectral density 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) 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 start5 Aug 2026
- Primary completion10 Sep 2026
- 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
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single-Arm Study of Closed-Loop Theta-Burst Stimulation (TBS) Targeting the Right Parietal-Occipital Cortex (rPO) for Core Clinical Features of Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT07775807
- Acronym / sponsor ID
- MZhao-030
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 session. Receive theta-burst stimulation targeting the right parietal-occipital cortex while completing 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed-loop Group | Experimental | Device: Closed-loop Theta-Burst Stimulation (TBS) Targeting rPOBefore stimulation: The researchers measure the participant's Resting Motor Threshold (RMT) and assess their craving using VAS before and after viewing 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 Electroencephalography (EEG) features will be used to trigger Transcranial Magnetic Stimulation (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop Theta-Burst Stimulation (TBS) Targeting rPOAlso: EEG-TMS, Closed-loop rPO-TBSParticipants 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. | Device | Closed-loop Group |
Primary outcome
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 power spectral density in response to methamphetamine-related cues.
2 secondary outcomes
Change in Cue-Induced Craving Measured by Visual Analog Scale (VAS)
Time frame: Before and within 30 minutes after stimulation
Change in Inhibitory Control Assessed by Stop Signal Task (SST)
Time frame: Before and within 30 minutes after stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cue-Induced Neural Reactivity During Before and After Stimulation (time frame: During cue-reactivity task in training and stimulation phases of each session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.