Clinical trial NCT06457230: Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the Frontopolar-Cerebellum
Official title: Exploration of the Intervention Mechanism and Efficacy of Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the Frontopolar-Cerebellum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amphetamine Use Disorders
Keywords: Paired-pulse
Repetitive transcranial magnetic stimulation
Cerebellum
Frontopolar cortex
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Craving assessed by Visual Analog Scale (VAS)
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Depression
timeFrame: through study completion, an average of 1 month
measure: Anxiety
timeFrame: through study completion, an average of 1 month
measure: Addiction stroop task
timeFrame: through study completion, an average of 1 month
measure: Changes of electroencephalogram power spectrum
timeFrame: through study completion, an average of 1 month
measure: Probabilistic inversion learning task
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Min Zhao, PhD
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Min Zhao, PhD
role: STUDY_CHAIR
References: