An interventional study of sham TBS and real mPFC cTBS in Amphetamine Use Disorders, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment
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.
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.
Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.
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Exclusion Criteria:
Sham TBS delivered on left dlPFC or medial prefrontal cortex of amphetamine-dependent patients. Stimulation pulses are the same as the real group.
Device: sham TBS
The real cTBS stimulation pattern will be delivered on the medial prefrontal cortex.
Device: real mPFC cTBS
The real iTBS stimulation pattern will be delivered on the left dorsal prefrontal cortex.
Device: real dlPFC iTBS
Combination therapy of real iTBS stimulation delivered on the left dorsal prefrontal cortex and real cTBS stimulation delivered on the medial prefrontal cortex.
Device: real dlPFC iTBS + real mPFC cTBS
Stimulate the dorsal lateral prefrontal cortex or medial prefrontal cortex for 2 weeks by sham Theta-burst stimulation (TBS), five times for a week with the sham coil.
Stimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern, and stimulate medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
Change of Craving assessed by Visual Analog Scale
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.
Time frame: 12 months.
Number of participants who relapse
Follow up with patients after discharge, evaluate number of participants who relapse
Time frame: 12 months
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
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.
Time frame: 12 months
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
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.
Time frame: 12 months
Cognitive function assessed by CogState Battery (CSB)
evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version
Time frame: 12 months
Response inhibition function
assessed by Go nogo task under the electroencephalogram recording
Time frame: 12 months
Cue reactivity
assessed by Cue reactivity task under the electroencephalogram recording
Time frame: 12 months
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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