Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder

Shanghai Mental Health Center

Status: Completed

Conditions: Amphetamine Use Disorders

Treatments: Device: sham TBS; Device: real dlPFC iTBS; Device: real dlPFC iTBS + real mPFC cTBS; Device: real mPFC cTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT03736317

MZhao-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 4 patient groups

control group

Sham Comparator group

Description:

Sham TBS delivered on left dlPFC or medial prefrontal cortex of amphetamine-dependent patients. Stimulation pulses are the same as the real group.

Treatment:

Device: sham TBS

real mPFC cTBS group

Experimental group

Description:

The real cTBS stimulation pattern will be delivered on the medial prefrontal cortex.

Treatment:

Device: real mPFC cTBS

real dlPFC iTBS group

Experimental group

Description:

The real iTBS stimulation pattern will be delivered on the left dorsal prefrontal cortex.

Treatment:

Device: real dlPFC iTBS

real dlPFC iTBS + real mPFC cTBS group

Experimental group

Description:

Combination therapy of real iTBS stimulation delivered on the left dorsal prefrontal cortex and real cTBS stimulation delivered on the medial prefrontal cortex.

Treatment:

Device: real dlPFC iTBS + real mPFC cTBS