Cerebellum-Prefrontal Paired-Pulse Stimulation for Methamphetamine Use Disorder

NCT06457230 | Recruiting

• 4 other identifiers: MZhao-0152021ZD02021052024YFF050760482130041, 82471510, U25C2016
• Study Type: interventional
• Target: 90
• 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 cerebellar-medial prefrontal cortex (mPFC) pulses on methamphetamine use disorder patients and to develop a novel physiotherapeutic intervention to optimise the treatment and management.

Conditions

Methamphetamine Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Craving

  The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale (VAS), where individuals rated their cravings on a scale from 0 to 100, with higher scores indicating greater levels of craving.

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

• 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. ).

  Probabilistic reversal learning task and volatile reversal learning task : baseline, post-intervention, and at a follow-up session one week later;

Secondary Outcomes (6)

• Other craving scales

  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) and immediately after the intervention (post-intervention).

• response inhibition

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

• 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 (3)

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 over cerebellum and mPFC

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

Cerebellar Sham + Real mPFC Stimulation Group

ACTIVE COMPARATOR

This group serves as the positive control group for single-site stimulation. Participants in this group will receive real stimulation over the medial prefrontal cortex combined with sham stimulation over the cerebellum. This design allows us to determine whether the therapeutic effects of paired cerebellum-medial prefrontal cortex stimulation are attributable to the paired stimulation protocol itself, rather than to the effect of single-target stimulation of the medial prefrontal cortex alone.

Device: Sham stimulation over the cerebellum + real stimulation over the medial prefrontal cortex

Interventions

Sham Intervention over cerebellum and mPFC 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

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 stimulation over the cerebellum + real stimulation over the medial prefrontal cortex DEVICE

Participants in this group will receive sham stimulation over the cerebellum (The coil will be placed vertically over the cerebellum) combined with real stimulation over the medial prefrontal cortex.

Cerebellar Sham + Real mPFC Stimulation Group

Eligibility Criteria

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

You may qualify if:

• Methamphetamine is the primary substance of use, and the participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate or severe methamphetamine use disorder;
• aged 18 to 60 years;
• normal or corrected-to-normal vision and hearing, and right-handedness;
• primary school education or above, with the ability to understand the questionnaires and behavioral task instructions.

You may not qualify if:

• Participants will be excluded if they meet any of the following criteria:
• presence of metal objects in the body, such as metal dentures, orthodontic braces, bone fixation plates, aneurysm clips, or other metallic implants;
• severe physical illness or chronic disease, including heart disease, severe hypertension, stroke, epilepsy, or history of head trauma;
• comorbid psychiatric disorders, such as bipolar disorder, schizophrenia, or severe depression;
• previous participation in transcranial magnetic stimulation- or electroencephalography-related studies;
• refusal to participate in the study, poor compliance, or any other contraindications to transcranial magnetic stimulation.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Chengdu Drug Rehabilitation Center: collaborator
• Sichuan Ziyang Compulsory Isolation Drug Rehabilitation Center: collaborator
• Mental Health Center, West China Hospital of Sichuan University, Chengdu: collaborator
• Wuhan Mental Health Center, The Ninth Clinical School, Tongji Medical College, Huazhong University of Science and Technology, Wuhan: collaborator
• HanYang Comoulsory Isolation Drug Rehabilitation Center, Wuhan: 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, OUTCOMES ASSESSOR
• 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: July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

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

Locations

CN (1)