Repetitive dTMS Intervention for Methamphetamine Addiction
Study Details
Study Description
Brief Summary
A growing body of evidence suggests a wide range of brain areas including medial prefrontal cortex (mPFC), dorsolateral prefrontal cortex (DLPFC) and other subcortical regions, such as anterior cingulate cortex (ACC) are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial magnetic stimulation (rTMS) over dorsolateral prefrontal cortex reduces craving for meth dependences. Specifically, the H7 coil induces a magnetic field can target mPFC and ACC. In this study, the investigators investigated whether repeated dTMS intervention of medial prefrontal and cingulate cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study will be conducted at the drug rehabilitation center in China. The whole procedure includes enrollment, pre-intervention evaluation, intervention (for 3 weeks, 5 times a week, 15 times in total), post-intervention evaluation and one month follow up evaluation.
In enrollment session, participants are recruited according to inclusion criteria.
In the pre-intervention evaluation, firstly, participants need complete a questionnaire to assess their demographic information, drug addiction history and drug abstinence. And then are assigned to either 10Hz group or sham group according to the counterbalance of their basic demographic and drug use information. Then, participants need complete craving, cognitive ability and electroencephalogram (EEG) assessment. For craving assessing, participants are shown a video of methamphetamine usage for 5 minutes, and then rated on the visual analogue scale (0 means completely undesired and 100 means extremely wanting) to report their craving for methamphetamine. For cognitive ability and EEG signal assessing, the whole process is conducted on the computer according to instructions.
In the intervention session, dTMS was administered using a TMS stimulator (Magstim, U.K.) equipped with a unique H-shaped coil design. The H-coil version used in this study was the H7 (Brainsway, Jerusalem, Israel). When placed 4-5 cm anterior to the foot motor cortex and used at 100% of the leg resting motor threshold (RMT), the H7 coil stimulates the dorsal mPFC and ACC bilaterally. A participant's RMT was determined before the first treatment and at the beginning of each week by ascertaining the coil position that elicited the minimal involuntary contractions of the feet (three of six attempts). The 10Hz group received 10 Hz dTMS at 100% of RMT, with 3-second pulse and 17-second intervals, for a total of 50 trains and 1500 pulses per session. The sham group received treatment with identical technical parameters, which induced scalp sensations but without penetration of the electric field into the brain.
Post-intervention evaluation and one month follow up evaluation are the same as in pre-intervention evaluation.
To ensure study quality, some measures are taken as bellow:
Researchers and drug rehabilitation staff will work together in whole process and the data will be converted into electronic versions once finishing each evaluation.
In the intervention, patients, operators, and raters were blind to treatment condition. Each patient is assigned a magnetic card that determined the coil (real or sham) in the helmet and raters are not present while treatments are administered.
After each treatment times, any side effect from participant's report are recorded to assure the safety and feasibility.
Statistical analyses are performed using SPSS 21.0. The principal statistical analysis is performed using repeated-measures analysis of variance and regression analysis. All missing data will be recorded and marked.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 10hz group a high frequency stimulation |
Device: real coil
active 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses
|
| Sham Comparator: sham group a sham coil which frequency is 10hz but do not induce stimulation |
Device: sham coil
sham 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses
|
Outcome Measures
Primary Outcome Measures
- Changes of Cue-induced craving and ERP [the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention]
Subjective craving (cue induced, 0-100 based VAS, craving scale) and drug cue-ERP (P300 etc. measured)
Secondary Outcome Measures
- Changes of cognition: behavioral inhibition [the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention]
using cognitive tasks: stop-signal task
- Changes of cognition: working memory [the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention]
using cognitive tasks: n-back task
- Changes of depression status [the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention]
depression (Beck Depression inventory scale), high score means worse depression
- Changes of anxiety status [the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention]
Anxiety (Beck anxiety inventory scale), higher score means worse anxiety
- Changes of sleep status [the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention]
sleep status measurements (Pittsburgh Sleep Quality Index scale), higher score means worse sleep
- Changes of impulsivity [the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention]
Impulsivity scale (The Barratt Impulsiveness Scale), higher score means higher impulsivity
- Changes of resting EEG network [the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention]
resting EEG signal (Alpha, Beta, Theta, etc) measurement with 128 Channel EGI system
Other Outcome Measures
- side effect measurements [every day after each intervention time for the 3 weeks intervention time period]
Side effect scale, including headache, pricking, sleeplessness etc.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Methamphetamine dependents
-
middle school degree or above
Exclusion Criteria:
-
Have contraindications to rTMS (head trauma, epilepsy or history of epilepsy, metal implant etc.)
-
psychiatric illnesses
-
intellectual impairment (IQ<90)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing Dalianshan Addiction Rehab Center | Nanjing | China | 210090 |
Sponsors and Collaborators
- Shanghai Mental Health Center
Investigators
- Principal Investigator: Tifei Yuan, PhD, Shanghai Mental Health Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
- Dunlop K, Hanlon CA, Downar J. Noninvasive brain stimulation treatments for addiction and major depression. Ann N Y Acad Sci. 2017 Apr;1394(1):31-54. doi: 10.1111/nyas.12985. Epub 2016 Feb 5. Review.
- Liu Q, Shen Y, Cao X, Li Y, Chen Y, Yang W, Yuan TF. Either at left or right, both high and low frequency rTMS of dorsolateral prefrontal cortex decreases cue induced craving for methamphetamine. Am J Addict. 2017 Dec;26(8):776-779. doi: 10.1111/ajad.12638. Epub 2017 Nov 14.
- Liu T, Li Y, Shen Y, Liu X, Yuan TF. Gender does not matter: Add-on repetitive transcranial magnetic stimulation treatment for female methamphetamine dependents. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jun 8;92:70-75. doi: 10.1016/j.pnpbp.2018.12.018. Epub 2018 Dec 31.
- Shen Y, Cao X, Tan T, Shan C, Wang Y, Pan J, He H, Yuan TF. 10-Hz Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex Reduces Heroin Cue Craving in Long-Term Addicts. Biol Psychiatry. 2016 Aug 1;80(3):e13-4. doi: 10.1016/j.biopsych.2016.02.006. Epub 2016 Feb 12.
- Su H, Zhong N, Gan H, Wang J, Han H, Chen T, Li X, Ruan X, Zhu Y, Jiang H, Zhao M. High frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex for methamphetamine use disorders: A randomised clinical trial. Drug Alcohol Depend. 2017 Jun 1;175:84-91. doi: 10.1016/j.drugalcdep.2017.01.037. Epub 2017 Mar 29.
- TFYuan