Exploration of the Intervention Mechanism and Efficacy of Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the mPFC-Cerebellum
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shanghai Mental Health Center
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- cognitive flexibility
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Detailed Description
Numerous studies have shown that impaired mPFC-cerebellar functional connectivity leads to impaired social preferences and behavioural flexibility and more persistent drug use in addicts. Cerebellar and mPFC paired-pulse rTMS interventions may enhance functional connectivity, effectively modulate cerebellar-prefrontal loops, reduce craving, improve cognitive flexibility, and reduce relapse risk. The aim of this project is to investigate the mechanism and efficacy of a novel paired-pulse rTMS intervention targeting the mPFC-cerebellar circuit in patients with methamphetamine use disorder, in order to develop innovative physiotherapeutic interventions and to optimize treatment and clinical management for individuals with addiction. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
cognitive flexibility
Time Frame: 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.
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.
Secondary Outcomes
- 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.)
- stress levels(before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.)
- sleep quality(before the intervention (baseline), immediately after the intervention (post-intervention), and at a follow-up session one weeks later.)