Actively Recruiting
Exploration of the Intervention Mechanism and Efficacy of Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the mPFC-Cerebellum
Led by Shanghai Mental Health Center · Updated on 2025-12-18
70
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
S
Shanghai Mental Health Center
Lead Sponsor
H
Hanyang Drug Rehabilitation Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new repetitive transcranial magnetic stimulation (rTMS) method using paired pulses targeting the medial prefrontal cortex (mPFC) and cerebellum to help patients with methamphetamine use disorder. This approach is based on evidence that poor connectivity between these brain areas contributes to drug craving, impaired social behavior, and relapse. The goal is to better understand how this brain stimulation can improve treatment and management of addiction. The study compares two groups: one receiving the paired-pulse rTMS stimulation with pulses delivered first to the cerebellum and then to the mPFC after a 6-millisecond delay, and a sham group receiving inactive stimulation that mimics the experience without therapeutic effect. Each active session involves 900 pulse pairs over about 12 minutes. The 6-ms delay was identified as optimal in a prior mechanistic study. The sham group experiences the coil vibration and sound but without effective stimulation. Participants will undergo assessments before, immediately after, and one week following the intervention to measure changes in cognitive flexibility, craving, brain electrical activity, response inhibition, depression, anxiety, stress, and sleep quality using various tasks and scales. The study includes random assignment to groups and double-blinding. Participation lasts through the intervention and follow-up sessions, allowing researchers to evaluate both immediate and short-term effects of the treatment.
CONDITIONS
Brief Title
Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the mPFC-Cerebellum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary substance of abuse is methamphetamine.
- Meets DSM-5 criteria for severe methamphetamine use disorder with 6 or more symptoms in the past year.
- Age between 18 and 60 years.
- Education level of primary school or above with ability to understand questionnaires and tasks.
- Normal vision and hearing.
- Right-handed.
- No prior participation in any TMS-related therapy.
You will not qualify if you...
- Presence of any metal implants or implanted medical devices like pacemakers or neurostimulators.
- Chronic or severe physical diseases such as cardiac conditions, uncontrolled hypertension, or physical disabilities.
- Comorbid psychiatric disorders including schizophrenia, depression, or anxiety disorders.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not specified
Participants receive paired-pulse rTMS treatment targeting the cerebellar-mPFC circuit or sham stimulation over multiple sessions to evaluate effects on craving, cognitive flexibility, and other outcomes.
Multiple treatment visits (exact number not specified)
Duration - 1 week
Participants are monitored for changes in cognitive flexibility, craving, and other behavioral and physiological outcomes one week after completing the intervention.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Min Zhao, PhD
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
M
Min Zhao, PhD
6
64387250 Zhao, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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