Cerebellum-Prefrontal Paired-Pulse Stimulation for Methamphetamine Use Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorShanghai Mental Health Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Sham Cerebellar Stimulation + Sham mPFC Stimulation GroupSham comparator 1 intervention
Group B: Cerebellar-mPFC Dual-Coil Paired-Pulse TMS Intervention GroupExperimental treatment 1 intervention
Group C: Cerebellar Sham + Real mPFC Stimulation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.
2

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. ).

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

Secondary outcomes

1

Other craving scales

1、Desires for drug questionnaire (DDQ) consists of 13 items designed to assess an individual's current thoughts and preoccupations related to drug use. 2、Obsessive Compulsive Drug Use Scale (OCDUS)consists of 13 items designed to assess an individual's current thoughts and preoccupations related to drug use.

Time frame
before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.
2

Electroencephalographic (EEG) Electrophysiological Results

This includes analyses of TMS-EEG, resting-state EEG, and task-state EEG data across temporal, frequency, and time-frequency domains.

Time frame
before the intervention (baseline) and immediately after the intervention (post-intervention).
3

response inhibition

The Stop-Signal Task (SST) is a seminal experimental paradigm in cognitive psychology and neuroscience designed to objectively measure an individual's response inhibition-the ability to actively suppress a prepotent or already-initiated motor response. To gain a more comprehensive understanding of an individual's inhibitory control, it is highly informative to complement this with a trait-based, self-reported measure of impulsivity.

Time frame
SST task: baseline, post-intervention, and at a follow-up session one weeks later.
4

Depression

The reduction rate of Beck Depression Inventory (BDI) scores was calculated from baseline to post-intervention and follow-up assessments to quantify the decrease in depressive symptom severity.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Mental Health Center

Lead sponsor

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