Amphetamine-Related Disorders
Conditions
Brief summary
The purpose of this research is to evaluate the efficacy of multiple sessions of theta-gamma cross-frequency transcranial alternating current stimulation in patients with methamphetamine (MA) use disorders.
Detailed description
Previous evidence suggests that different aspects of cognitive function are associated with activities of distinct EEG frequency bands. Gamma oscillatory has been found in clinical studies to reflect the processing of rewards in patients with drug dependence, whereas medial prefrontal theta oscillatory characterizes prefrontal response inhibition capacity to downstream reward arousal. Interestingly, impaired response inhibition or impaired evaluation of rewards in patients with drug dependence have been found to correlate with the arousal of psychological craving and the emergence of relapse. Here we aim to find causal evidence supporting these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands (theta-gamma) previously shown to be addiction-relevant. In a randomized control clinical trial design, we stimulate subjects with either theta-gamma or sham tACS. Electroencephalography will be collected before and after each treatment session. Besides, the scale and behavior task data will also collected before and after the treatment.
Interventions
DEVICECross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device
Stimulation will be delivered via the Neuroelectrics Starstim 32 transcranial electric stimulation device, an investigational electrical non-invasive brain stimulation device that is being used for clinical and translational research.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
1. In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders 2. Normal vision and hearing 3. Dextromanual 4. Use MA not less than 1 year, and the last of MA use no less than 3 months
Exclusion criteria
1. Have a disease that affects cognitive function such as a history of head injury, cerebrovascular disease, epilepsy, etc 2. Have cognitive-promoting drugs in the last 6 months 3. Other substance abuse or dependence in recent five years (except nicotine) 4. Meet the DSM-5 criteria for other mental disorders 5. Physical disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Craving assessed by Visual Analog Scale | baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety status assessed by Beck Anxiety Inventory (BAI) | baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment | The reduction rate in the Beck Anxiety Inventory (BAI) scores was calculated before and after treatment to assess the rate of decrease in anxiety levels among MA dependents. |
| Sleep Quality Assessment | baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment | Sleep Quality is assessed by the scores of Insomnia Severity Index(ISI) and Pittsburgh Sleep Quality Index(PSQI). |
| Depression status assessed by Beck Depression Inventory (BDI) | baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment | The reduction rate in the Beck Depression Inventory (BDI) scores was calculated before and after the treatment to evaluate the rate of reduction in their levels of depression. |
| Reward learning | baseline，0-2 days after treatment, 3 months after treatment | Learning rate and the sensitivity to rewards assessed by Monetary reinforcement learning task under the electroencephalogram recording, and the results will be derived from modeling. |
| Spatial working memory | baseline，0-2 days after treatment, 3 months after treatment | Working memory capacity is assessed by Spatial working memory under the electroencephalogram recording. The indicator is the correctness and response time. |
| Brain oscillations | baseline，within 30 minutes before and after each session of treatment | Assessed by Resting EEG task under the electroencephalogram recording to extract alpha, beta, theta, and gamma band energy. |
Countries
China
Contacts
Primary ContactMin Zhao, PhD
Backup ContactTianzhen Chen, PhD
Outcome results
None listed