Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the mPFC-Cerebellum

NCT06457230 | Recruiting

• 1 other identifier: MZhao-015
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the mechanism and efficacy of a novel repetitive transcranial magnetic stimulation (rTMS) intervention model with paired medial prefrontal cortex (mPFC) -cerebellar pulses on methamphetamine use in patients and to develop a novel physiotherapeutic intervention to optimise the treatment and management of addicted patients.

Conditions

Methamphetamine Use Disorder

Keywords

Repetitive transcranial magnetic stimulation; Cerebellum; Frontopolar cortex; Methamphetamine; Cortico-Cortical Paired Associative Stimulation

Outcome Measures

Primary Outcomes (1)

• cognitive flexibility

  Based on tasks and scales assessing cognitive flexibility, including: 1.Probabilistic reversal learning task (The matching of symbols and pictures was reversed without informing the subjects and their cognitive flexibility in the reversed condition was assessed); 2.Volatile reversal learning task (participants were presented with two stimuli associated with their potential feedback magnitude. They were instructed to choose one of the two stimuli to receive feedback, but only one stimulus would result in feedback. ); 3.The Wisconsin Card Sorting Test (WCST) (a classic neuropsychological task where participants match response cards to four key cards based on hidden sorting rules (color, shape, or number). They receive "right" or "wrong" feedback after each match and must deduce the current rule, which changes without warning after several consecutive correct matches.); 4. The Cognitive Flexibility Inventory (CFI) scale is a 20-item self-report measure.

  Probabilistic reversal learning task: baseline, post-intervention, and at a follow-up session one weeks later; Volatile reversal learning task and Wisconsin Card Sorting Test: baseline and post-intervention; The CFI scale: baseline.

Secondary Outcomes (7)

• Craving

  before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.

• Electroencephalographic (EEG) Electrophysiological Results

  before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.

• response inhibition

  SST task: baseline, post-intervention, and at a follow-up session one weeks later; BIS-11 scale: baseline.

• Depression

  before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.

• Anxiety

  before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.

Study Arms (2)

Sham Cerebellar Stimulation + Sham mPFC Stimulation Group

SHAM COMPARATOR

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.

Device: Sham Intervention Group

Cerebellar-mPFC Dual-Coil Paired-Pulse TMS Intervention Group

EXPERIMENTAL

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.

Device: Paired Associative Stimulation Targeting the Cerebellar-mPFC

Interventions

Paired Associative Stimulation Targeting the Cerebellar-mPFC DEVICE

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.

Cerebellar-mPFC Dual-Coil Paired-Pulse TMS Intervention Group

Sham Intervention Group DEVICE

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 Cerebellar Stimulation + Sham mPFC Stimulation Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primary substance of abuse is methamphetamine.
• Meets the DSM-5 diagnostic criteria for severe methamphetamine use disorder (≥6 symptoms present within the past year).
• Age: 18-60 years.
• Education level of primary school or above, with the ability to comprehend questionnaires and behavioral tasks.
• Normal vision and hearing; right-handed.
• No prior participation in any TMS-related intervention therapy.

You may not qualify if:

• Presence of any metallic implants (e.g., dental prostheses, orthodontic braces, bone fixation plates, aneurysm clips, intrauterine devices) or implanted medical devices such as cardiac pacemakers or neurostimulators.
• Chronic or severe somatic diseases (e.g., cardiac conditions, uncontrolled hypertension, physical disabilities).
• Comorbid psychiatric disorders (e.g., schizophrenia, depressive disorders, anxiety disorders).

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Hanyang Drug Rehabilitation Center: collaborator
• Chengdu Drug Rehabilitation Center: collaborator

Study Sites (1)

Min Zhao, PhD

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Officials

• Min Zhao, PhD

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Min Zhao, PhD

CONTACT

64387250; drminzhao@gmail.com

64387250 Zhao, PhD

CONTACT

64387250; drminzhao@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: December 24, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)