Ireland
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Recruiting Not applicable

Cerebellum-Prefrontal Paired-Pulse Stimulation for Methamphetamine Use Disorder

NCT06457230 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-12-24
Last updated
2026-06-24

Condition(s) studied

Methamphetamine Use Disorder

Investigational drug(s) / intervention(s)

Paired Associative Stimulation Targeting the Cerebellar-mPFCSham Intervention over cerebellum and mPFCSham stimulation over the cerebellum + real stimulation over the medial prefrontal cortex

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 over cerebellum and mPFC: 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 stimulation over the cerebellum + real stimulation over the medial prefrontal cortex: 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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria Participants will be eligible for inclusion if they meet the following criteria: 1. 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; 2. aged 18 to 60 years; 3. normal or corrected-to-normal vision and hearing, and right-handedness; 4. primary school education or above, with the ability to understand the questionnaires and behavioral task instructions. Exclusion Criteria Participants will be excluded if they meet any of the following criteria: 1. presence of metal objects in the body, such as metal dentures, orthodontic braces, bone fixation plates, aneurysm clips, or other metallic implants; 2. severe physical illness or chronic disease, including heart disease, severe hypertension, stroke, epilepsy, or history of head trauma; 3. comorbid psychiatric disorders, such as bipolar disorder, schizophrenia, or severe depression; 4. previous participation in transcranial magnetic stimulation- or electroencephalography-related studies; 5. refusal to participate in the study, poor compliance, or any other contraindications to transcranial magnetic stimulation.

Primary outcome measure(s)

  • Craving — before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.
    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.
  • cognitive flexibility — Probabilistic reversal learning task and volatile reversal learning task : baseline, post-intervention, and at a follow-up session one week later;
    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. ).

Trial sites (1)

FacilityCityRegionStatus
Min Zhao, PhD Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06457230 on ClinicalTrials.gov ↗ ← All trials in China