Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the Frontopolar-Cerebellum
- Conditions
- Amphetamine Use Disorders
- Interventions
- Device: 10Hz rTMS based on cerebellum and FPCDevice: 10Hz rTMS based on cerebellum or FPC
- Registration Number
- NCT06457230
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
To investigate the mechanism and efficacy of a novel repetitive transcranial magnetic stimulation (rTMS) intervention model with paired frontopolar cortex (FPC) -cerebellar pulses on episodic methamphetamine use in patients on methadone maintenance treatment and to develop a novel physiotherapeutic intervention to optimise the treatment and management of addicted patients.
- Detailed Description
Numerous studies have shown that impaired FPC-cerebellar functional connectivity leads to impaired social preferences and behavioural flexibility and more persistent drug use in addicts. Cerebellar and FPC 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 explore the mechanism and efficacy of a novel FPC-cerebellar paired-pulse rTMS intervention model on occasional methamphetamine use in methadone maintenance patients, to develop novel physiotherapy interventions, and to optimise the treatment and management of addicted patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
-
Individuals aged between 18 and 60 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
- Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
- A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
- Consent to actively cooperate in the completion of subsequent follow-up assessments.
-
Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
- A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
- Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
- Severe organic diseases that might compromise study participation.
- Contraindications to rTMS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paired-pulse rTMS based on cerebellum and FPC for substance use disorder 10Hz rTMS based on cerebellum and FPC Randomly assigned cerebellar + FPC sequential intervention group (20 people). The cerebellar + FPC sequential intervention group was designed with a block programme of cerebellar and FPC stimulation at 100 ms intervals (each block: cerebellar 10 Hz rTMS stimulation - 100 ms interval - frontal pole 10 Hz rTMS stimulation). Single pulse rTMS based on cerebellar or FPC for substance use disorder 10Hz rTMS based on cerebellum or FPC Participants will be subjected to 10 Hz rTMS based on cerebellar or FPC (20 people). The randomised intervention group randomly intervened in either the cerebellum or the FPC, with the stimulation parameters remaining the same as in the experimental group.
- Primary Outcome Measures
Name Time Method Change of Craving assessed by Visual Analog Scale (VAS) through study completion, an average of 1 month 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 10, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation.
- Secondary Outcome Measures
Name Time Method Depression through study completion, an average of 1 month The reduction rate in the Beck Depression Inventory (BDI) scores was calculated before and after the intervention to evaluate the rate of reduction in their levels of depression.
Addiction stroop task through study completion, an average of 1 month By testing reaction time and rate of correct response to detect multiple cognitive abilities such as attention selection, processing speed, executive functions, and cognitive inhibition by testing reaction time and correct response rate.
Anxiety through study completion, an average of 1 month The reduction rate in the Beck Anxiety Inventory (BAI) scores was calculated before and after intervention to assess the rate of decrease in anxiety levels among MA dependents.
Changes of electroencephalogram power spectrum through study completion, an average of 1 month Resting-state EEG can be used to extract power spectra and electrode functional connectivity; on-task EEG can be used to isolate time-frequency features during non-stimulated trials to extract alpha, beta, theta, and gamma band energy of the parietal and occipital electrodes. Both can be used to assess changes in neural activity before, during, and after their restimulation.
Probabilistic inversion learning task through study completion, an average of 1 month The matching of symbols and colours was reversed without informing the subjects and their cognitive flexibility in the reversed condition was assessed
Trial Locations
- Locations (1)
Min Zhao, PhD
🇨🇳Shanghai, Shanghai, China