- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03736317
Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder
September 13, 2021 updated by: Shanghai Mental Health Center
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Craving in Methamphetamine Use Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 201900
- Shanghai Compulsory Rehabilitation Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: control group
Sham TBS delivered on left dlPFC or medial prefrontal cortex of amphetamine-dependent patients.
Stimulation pulses are the same as the real group.
|
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.
|
Experimental: real mPFC cTBS group
The real cTBS stimulation pattern will be delivered on the medial prefrontal cortex.
|
Stimulate the medial prefrontal cortex with the cTBS pattern.
The therapy will be conducted for 2 weeks and five times for a week.
|
Experimental: real dlPFC iTBS group
The real iTBS stimulation pattern will be delivered on the left dorsal prefrontal cortex.
|
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern.
The therapy will be conducted for 2 weeks and five times for a week.
|
Experimental: real dlPFC iTBS + real mPFC cTBS group
Combination therapy of real iTBS stimulation delivered on the left dorsal prefrontal cortex and real cTBS stimulation delivered on the medial prefrontal cortex.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Craving assessed by Visual Analog Scale
Time Frame: 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.
|
12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who relapse
Time Frame: 12 months
|
Follow up with patients after discharge, evaluate number of participants who relapse
|
12 months
|
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
Time Frame: 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.
|
12 months
|
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
Time Frame: 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.
|
12 months
|
Cognitive function assessed by CogState Battery (CSB)
Time Frame: 12 months
|
evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version
|
12 months
|
Response inhibition function
Time Frame: 12 months
|
assessed by Go nogo task under the electroencephalogram recording
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12 months
|
Cue reactivity
Time Frame: 12 months
|
assessed by Cue reactivity task under the electroencephalogram recording
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Min Zhao, PhD, Shanghai Mental Health Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
November 6, 2018
First Submitted That Met QC Criteria
November 7, 2018
First Posted (Actual)
November 9, 2018
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MZhao-009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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