Treatment Effect of Cross-frequency Transcranial Alternating Current Stimulation on the MUD

Amphetamine-Related Disorders Clinical Trial

Official title:

The Exploration of Novel Cross-frequency Protocol of Transcranial Alternating Current Stimulation in the Treatment of Methamphetamine Use Disorder: A Randomized Sham-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145698
• Other study ID #: MZhao-014
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: October 2023
• Source: Shanghai Mental Health Center
• Contact: Min Zhao, PhD
• Phone: 021-54252689
• Email: 18017311005[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: February 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Amphetamine-Related Disorders

Intervention

Device:
• Cross-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.

Locations

Country	Name	City	State
China	Wuhan Compulsory Rehabilitation Center	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline,0-2 days after treatment,1 months after treatment, 3 months after treatment
Secondary	Depression status assessed by Beck Depression Inventory (BDI)	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.	baseline,0-2 days after treatment,1 months after treatment, 3 months after treatment
Secondary	Anxiety status assessed by Beck Anxiety Inventory (BAI)	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.	baseline,0-2 days after treatment,1 months after treatment, 3 months after treatment
Secondary	Sleep Quality Assessment	Sleep Quality is assessed by the scores of Insomnia Severity Index(ISI) and Pittsburgh Sleep Quality Index(PSQI).	baseline,0-2 days after treatment,1 months after treatment, 3 months after treatment
Secondary	Brain oscillations	Assessed by Resting EEG task under the electroencephalogram recording to extract alpha, beta, theta, and gamma band energy.	baseline,within 30 minutes before and after each session of treatment
Secondary	Reward learning	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.	baseline,0-2 days after treatment, 3 months after treatment
Secondary	Spatial working memory	Working memory capacity is assessed by Spatial working memory under the electroencephalogram recording. The indicator is the correctness and response time.	baseline,0-2 days after treatment, 3 months after treatment