Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence
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|ClinicalTrials.gov Identifier: NCT03827785|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine-dependence||Device: rTMS treatment group Device: sham rTMS treatment group||Not Applicable|
First, a multicenter, double-blind, randomized control study is going to be carried out. 100 recruited patients will be randomized assigned to the intervention group and the control group, receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS) treatment or 4-week of sham rTMS treatment. Both groups will receive 12-week urine drug test follow-up (1 time per week). Negative rate of urine test during the follow-up period is set as primary outcome. Cognitive function, craving, depression are also evaluated before and after the intervention.
Secondly, another 40 patients will be recruited from these 100 patients (20 subjects each group). Magnetic resonance spectroscopy (MRS) test is applied to investigate the potential neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an evidence-based rTMS treatment protocols for MA dependent patients and decrease risk of relapse for both the patients and their families.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||The Efficacy and Safety of Repeated Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence: a Multicenter, Double-blind, Randomized Controlled Clinical Trial|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||December 12, 2020|
Experimental: rTMS treatment group
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 30 days.
Device: rTMS treatment group
For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days.
Sham Comparator: sham rTMS treatment group
Stimulate the dorsal lateral prefrontal cortex with the sham iTBS pattern and coil. The therapy will be conductedfor 30 days.
Device: sham rTMS treatment group
For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days.
- Negative rate urine test [ Time Frame: 12 weeks ]
After treatment, patients will be asked to participate urine test for 12 times once a week. Loss of visit or rejection for urine test will be treated as urine test positive.
Negative rate of urine drug test = actual number of negative urine tests / 12.
- Change of Craving assessed by Visual Analog Scale [ Time Frame: 12 weeks ]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.
- Cognitive function assessed by CogState Battery (CSB) [ Time Frame: 12 weeks ]evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version
- Depression status assessed by Hamilton depression scale (HAMD-17) [ Time Frame: 12 weeks ]Evaluate all participants' depression status by Hamilton depression scale (HAMD-17) HAMD can be summarized into 7 types of factor structure: (1) anxiety/somatization:; (2) weight: weight loss (3) Cognitive obstacles; (4) day and night changes; (5) Block; (6) sleep disorder; (7) feeling of despair. The total score can reflect the severity of the symptom, that is, The lighter the symptoms, the lower the score, and vice versa. Mild depression: HAMD 17 scores > 7 points, ≤ 17 points; moderate depression: HAMD 17 scores > 17 points, ≤ 24 points; severe depression: HAMD 17 scores > 24 points.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827785
|Contact: Haifeng Jiangemail@example.com|
|Shanghai Rehabilitation Center||Recruiting|
|Shanghai, China, 200010|
|Contact: Daqing Shi|
|Principal Investigator:||Haifeng Jiang||Shanghai Mental Health Center|