Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the Frontopolar-Cerebellum

Amphetamine Use Disorders Clinical Trial

Official title:

Exploration of the Intervention Mechanism and Efficacy of Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the Frontopolar-Cerebellum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06457230
• Other study ID #: MZhao-015
• Status: Recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Shanghai Mental Health Center
• Contact: Min Zhao, PhD
• Phone: 64387250
• Email: drminzhao[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Amphetamine Use Disorders

Intervention

Device:
• 10Hz rTMS based on cerebellum and FPC
We compare the efficacy of paired-pulse stimulation relative to single-pulse stimulation. Subjects will be randomly assigned to a cerebellar + frontal pole paired-pulse experimental group.
• 10Hz rTMS based on cerebellum or FPC
Subjects will be randomly assigned to a cerebellar or frontal pole randomised control group.

Locations

Country	Name	City	State
China	Min Zhao, PhD	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Craving assessed by Visual Analog Scale (VAS)	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.	through study completion, an average of 1 month
Secondary	Depression	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.	through study completion, an average of 1 month
Secondary	Anxiety	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.	through study completion, an average of 1 month
Secondary	Addiction stroop task	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.	through study completion, an average of 1 month
Secondary	Changes of electroencephalogram power spectrum	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.	through study completion, an average of 1 month
Secondary	Probabilistic inversion learning task	The matching of symbols and colours was reversed without informing the subjects and their cognitive flexibility in the reversed condition was assessed	through study completion, an average of 1 month