Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder

Not Applicable

Completed

• Conditions: Amphetamine Use Disorders
• Interventions: Device: sham TBS; Device: real dlPFC iTBS; Device: real dlPFC iTBS + real mPFC cTBS; Device: real mPFC cTBS

• Registration Number: NCT03736317
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use disorder in previous studies, while the evidence-based protocols still required. The aim of this research is to develop more applicable rTMS intervention pattern and protocols to reduce craving and relapse of methamphetamine-dependent patients.

Detailed Description

The limbic circuit and executive control circuit are two important frontal-striatal neural circuits associated with drug dependence. Previous studies showed increased functional activity within the limbic neural circuit (e.g. medial prefrontal cortex (mPFC) and ventral striatum) in the presence of a salient cue and decreased activity in the executive control circuit (e.g. dorsal prefrontal cortex and dorsal striatum). TMS was used to reverse the activities of these two circuits, by using continuous TBS and intermittent TBS, respectively. In this study, vmPFC cTBS was conducted to modulating the limbic circuit, while left dlPFC iTBS was conducted to modulating the executive control circuit. Combined treatment of vmPFC cTBS and left dlPFC iTBS was conducted to modulating two circuits simultaneously. Focused on evaluating the efficacy of the interventions and investigate the mechanisms, neuropsychological tests, biochemical tests, and electroencephalography will be used to investigate the neurobiological mechanism of the methamphetamine use disorder, craving, and relapse. The study will be very helpful to develop evidence-based rTMS protocols for methamphetamine-dependent patients in clinical practice and decrease harm for both the patients and their families.

Study Timeline

• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Study Start: 2019-09-01
• Primary Completion: 2021-02-01
• Status Verified: 2021-09
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
• Primary school degree or above
• Normal vision and hearing
• Dextromanual
• Less than one month before last drug use

Exclusion Criteria

• Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
• Have cognitive-promoting drugs in the last 6 months
• Other substance abuse or dependence in recent five years (except nicotine)
• Mental impairment, Intelligence Quotient (IQ) < 70
• Mental disorders
• Physical disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	sham TBS	Sham TBS delivered on left dlPFC or medial prefrontal cortex of amphetamine-dependent patients. Stimulation pulses are the same as the real group.
real dlPFC iTBS group	real dlPFC iTBS	The real iTBS stimulation pattern will be delivered on the left dorsal prefrontal cortex.
real dlPFC iTBS + real mPFC cTBS group	real dlPFC iTBS + real mPFC cTBS	Combination therapy of real iTBS stimulation delivered on the left dorsal prefrontal cortex and real cTBS stimulation delivered on the medial prefrontal cortex.
real mPFC cTBS group	real mPFC cTBS	The real cTBS stimulation pattern will be delivered on the medial prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
Change of Craving assessed by Visual Analog Scale	12 months.	evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.

Secondary Outcome Measures

Name	Time	Method
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)	12 months	evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9), PHQ-9 range from 0 to 27, and higher values represent more severe level of depression.
Response inhibition function	12 months	assessed by Go nogo task under the electroencephalogram recording
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)	12 months	evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7). PHQ-9 range from 0 to 21, and higher values represent more severe level of anxiety.
Cognitive function assessed by CogState Battery (CSB)	12 months	evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version
Number of participants who relapse	12 months	Follow up with patients after discharge, evaluate number of participants who relapse
Cue reactivity	12 months	assessed by Cue reactivity task under the electroencephalogram recording

Trial Locations

Locations (1)

Shanghai Compulsory Rehabilitation Center; 🇨🇳 Shanghai, Shanghai, China