Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the mPFC-Cerebellum
NCT ID: NCT06457230
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-12-24
2026-08-31
Brief Summary
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Detailed Description
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Prior to initiating the intervention, it was essential to determine the optimal inter-stimulus interval (ISI) for the cerebellar-mPFC paired associative stimulation. Therefore, a mechanistic study was conducted from December 2024 to June 2025 at the Chengdu Drug Rehabilitation Center in Sichuan Province before the interventional trial commenced. A mixed design was employed, contrasting single-pulse mPFC stimulation with cerebellum→mPFC cortico-cortical paired associative stimulation (ccPAS) at inter-stimulus intervals of 6 ms and 45 ms. The results revealed that individuals with methamphetamine use disorder exhibited aberrant cerebellar-mPFC circuit connectivity compared to healthy controls. Importantly, cerebellar-mPFC ccPAS with a 6-ms ISI was found to specifically modulate this inter-regional circuit dysfunction.
Therefore, based on the identified 6-ms cerebellar-mPFC stimulation interval, the current interventional study continues to implement a long-term, dual-coil combined stimulation protocol to further evaluate and establish its therapeutic efficacy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham Cerebellar Stimulation + Sham mPFC Stimulation Group
This is the sham stimulation group. The coil will be placed vertically over the cerebellar and mPFC brain regions, allowing participants to perceive the coil's vibration and sound without receiving effective intervention. All other stimulation parameters are identical to those in the active intervention group.
Sham Intervention Group
The coil will be placed vertically over the cerebellar and mPFC brain regions, allowing participants to perceive the coil's vibration and sound without receiving effective intervention. All other stimulation parameters are identical to those in the active intervention group.
Cerebellar-mPFC Dual-Coil Paired-Pulse TMS Intervention Group
The stimulation protocol involved delivering a pulse to the cerebellum first, followed by a pulse to the mPFC after a 6ms inter-stimulus interval (ISI). This 6ms interval was determined based on findings from our prior mechanistic study.
Paired Associative Stimulation Targeting the Cerebellar-mPFC
The protocol consisted of 180 pulse trains. Each train contained 5 pulse pairs delivered over 1 second, resulting in a stimulation frequency of 5 Hz. Within each pulse pair, the cerebellum was stimulated first, followed by the mPFC after a 6-ms inter-stimulus interval (ISI). In total, 900 pulse pairs were administered, and a complete intervention session lasted 11 minutes and 57 seconds.
Interventions
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Paired Associative Stimulation Targeting the Cerebellar-mPFC
The protocol consisted of 180 pulse trains. Each train contained 5 pulse pairs delivered over 1 second, resulting in a stimulation frequency of 5 Hz. Within each pulse pair, the cerebellum was stimulated first, followed by the mPFC after a 6-ms inter-stimulus interval (ISI). In total, 900 pulse pairs were administered, and a complete intervention session lasted 11 minutes and 57 seconds.
Sham Intervention Group
The coil will be placed vertically over the cerebellar and mPFC brain regions, allowing participants to perceive the coil's vibration and sound without receiving effective intervention. All other stimulation parameters are identical to those in the active intervention group.
Eligibility Criteria
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Inclusion Criteria
2. Meets the DSM-5 diagnostic criteria for severe methamphetamine use disorder (≥6 symptoms present within the past year).
3. Age: 18-60 years.
4. Education level of primary school or above, with the ability to comprehend questionnaires and behavioral tasks.
5. Normal vision and hearing; right-handed.
6. No prior participation in any TMS-related intervention therapy.
Exclusion Criteria
2. Chronic or severe somatic diseases (e.g., cardiac conditions, uncontrolled hypertension, physical disabilities).
3. Comorbid psychiatric disorders (e.g., schizophrenia, depressive disorders, anxiety disorders).
18 Years
60 Years
MALE
Yes
Sponsors
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Hanyang Drug Rehabilitation Center
UNKNOWN
Chengdu Drug Rehabilitation Center
UNKNOWN
Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Min Zhao, PhD
Role: STUDY_CHAIR
Shanghai Mental Health Center
Locations
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Min Zhao, PhD
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Min Zhao, PhD
Role: primary
Min Zhao, PhD
Role: backup
Other Identifiers
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MZhao-015
Identifier Type: -
Identifier Source: org_study_id