Methamphetamine Use DisorderNCT07154160
Closed-loop TMS for the Core Clinical Features of Methamphetamine Use Disorder
A study testing Closed-loop TMS, Conventional TMS and Random TMS 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 transcranial magnetic stimulation (TMS) targeting left-dorsolateral prefrontal cortex (l-DLPFC) 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 TMS, Conventional TMS and Random TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- Oct 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 Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth 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.
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 Single-blind, Randomized, Parallel Study of Closed-loop, Conventional and Random TMS for Core Clinical Features of Methamphetamine Use Disorder.
The goal of this clinical trial is to evaluate whether closed-loop transcranial magnetic stimulation (TMS) targeting left-dorsolateral prefrontal cortex (l-DLPFC) 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 TMS targeting l-DLPFC 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 targeting l-DLPFC 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 targeting l-DLPFC to determine whether closed-loop yields superior symptom improvement.
Participants will:
Be randomly assigned to one of the three stimulation groups (closed-loop, conventional and random) according to a pre-generated random number table, and receive the corresponding stimulation session targeting l-DLPFC.
Undergo cue-reactivity assessment using VAS and cue-reactivity task, and complete the SST before and after each stimulation session.
- Being tested
- Closed-loop TMS, Conventional TMS, Random TMS
- 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 TMSDevice
Also called EEG-TMS, Closed-loop TBS, EEG triggered TMS
Participants receive theta burst stimulation (TBS) targeting l-DLPFC, triggered by real-time EEG signals recorded during a cue-reactivity task. This closed-loop protocol aims to deliver stimulation precisely during neural states associated with cue-induced craving.
Conventional TMSDevice
Participants receive TBS targeting l-DLPFC, delivered at a standard iTBS protocol (3-pulse 50-Hz bursts given at every 200 ms (i.e. at 5 Hz), 2s on and 8s off, with 1200 pulses in total), without EEG or task engagement.
Random TMSDevice
Participants receive TBS targeting l-DLPFC, triggered by a random sequence unrelated to real-time EEG features.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop Group | Experimental | 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 viewing a methamphetamine-related video.
The participants complete SST.
During the stimulation phase, participants will:
First undergo a training phase, during which EEG is 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 are used to trigger TMS in a closed-loop mode, targeting l-DLPFC.
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. Receives: Device: Closed-loop TMS |
| Conventional TMS Group | Active comparator | 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 viewing a methamphetamine-related video.
The participants complete SST.
During the stimulation phase, participants will:
First undergo a training phase, during which EEG is 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, targeting l-DLPFC, and 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. Receives: Device: Conventional TMS |
| Random Group | Active comparator | 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 viewing a methamphetamine-related video.
The participants complete SST.
During the stimulation phase, participants will:
First undergo a training phase, during which EEG is recorded while they perform a cue-reactivity task to identify neural signatures and calculate stimulation thresholds.
Then perform the cue-reactivity task again, and TMS is triggered by a random sequence unrelated to real-time EEG features, targeting l-DLPFC.
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: Random TMS |
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 TMS). The primary outcome will be changes in cue-induced neural reactivity, defined by EEG features in response to methamphetamine-related cues identified in previous studies, which are also implemented to trigger stimulation in this trial. Comparisons will be made across phases (pre- vs. during stimulation) and stimulation conditions (closed-loop, conventional, random).
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). Craving scores will be recorded immediately before and after each stimulation session under all three stimulation conditions.
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 across different stimulation conditions.
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 posted4 Sep 2025
- Study startOct 2026 (estimated)
- Primary completionOct 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.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, PhD, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154160
- Sponsor's protocol ID
- MZhao-021
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2025
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Parallel Study of Closed-loop, Conventional and Random TMS for Core Clinical Features of Methamphetamine Use Disorder.
- ClinicalTrials.gov ID
- NCT07154160
- Acronym / sponsor ID
- MZhao-021
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Sep 2025 (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 transcranial magnetic stimulation (TMS) targeting left-dorsolateral prefrontal cortex (l-DLPFC) 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 targeting l-DLPFC 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 targeting l-DLPFC 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 targeting l-DLPFC to determine whether closed-loop yields superior symptom improvement.
Participants will:
Be randomly assigned to one of the three stimulation groups (closed-loop, conventional and random) according to a pre-generated random number table, and receive the corresponding stimulation session targeting l-DLPFC.
Undergo cue-reactivity assessment using VAS and cue-reactivity task, and complete the SST before and after each stimulation session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Closed-loop Group | Experimental | Device: Closed-loop TMSParticipants 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 viewing a methamphetamine-related video. The participants complete SST. During the stimulation phase, participants will: First undergo a training phase, during which EEG is 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 are used to trigger TMS in a closed-loop mode, targeting l-DLPFC. 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. |
| Conventional TMS Group | Active comparator | Device: Conventional TMSParticipants 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 viewing a methamphetamine-related video. The participants complete SST. During the stimulation phase, participants will: First undergo a training phase, during which EEG is 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, targeting l-DLPFC, and 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. |
| Random Group | Active comparator | Device: Random TMSParticipants 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 viewing a methamphetamine-related video. The participants complete SST. During the stimulation phase, participants will: First undergo a training phase, during which EEG is recorded while they perform a cue-reactivity task to identify neural signatures and calculate stimulation thresholds. Then perform the cue-reactivity task again, and TMS is triggered by a random sequence unrelated to real-time EEG features, targeting l-DLPFC. 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 (3 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 Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth 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.
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 TMSAlso: EEG-TMS, Closed-loop TBS, EEG triggered TMSParticipants receive theta burst stimulation (TBS) targeting l-DLPFC, triggered by real-time EEG signals recorded during a cue-reactivity task. This closed-loop protocol aims to deliver stimulation precisely during neural states associated with cue-induced craving. | Device | Closed-loop Group |
| Conventional TMSParticipants receive TBS targeting l-DLPFC, delivered at a standard iTBS protocol (3-pulse 50-Hz bursts given at every 200 ms (i.e. at 5 Hz), 2s on and 8s off, with 1200 pulses in total), without EEG or task engagement. | Device | Conventional TMS Group |
| Random TMSParticipants receive TBS targeting l-DLPFC, triggered by a random sequence unrelated to real-time EEG features. | Device | Random 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 TMS). The primary outcome will be changes in cue-induced neural reactivity, defined by EEG features in response to methamphetamine-related cues identified in previous studies, which are also implemented to trigger stimulation in this trial. Comparisons will be made across phases (pre- vs. during stimulation) and stimulation conditions (closed-loop, conventional, random).
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 2 Nov 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.
Min Zhao, PhD study chair
Shanghai Mental Health Center
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 TMS, Conventional TMS and Random TMS 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 3 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: opening soon, as of the sponsor's last update on 2 Nov 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?
Contact Min Zhao, PhD (+86 18017311005, drminzhao@smhc.org.cn), or a site near the patient. 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 2 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.