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

December 6, 2023 updated by: Shanghai Mental Health Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

32

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 Contact

Study Contact Backup

Study Locations

  • China
      • Wuhan, China, 430000
        • Recruiting
        • Wuhan Compulsory Rehabilitation Center
        • Contact:
          • Hang Su

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

  • Adult

Accepts Healthy Volunteers

No

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: theta-gamma tACS
The study is investigating the use of transcranial alternating current stimulation (tACS). For the experimental arm, the stimulation is delivered at 2 milliamperes (mA) with the stimulation electrode over the left prefrontal cortex (F3) and left orbitofrontal cortex (Fp1) using the cross-frequency stimulation waveform theta-gamma.
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.
Sham Comparator: Active-sham tACS
For the active sham stimulation, the stimulation is delivered for 12 seconds with the theta-gamma cross-frequency stimulation waveform and then returns to baseline. The stimulus parameter of the sham stimulation is designed to mimic the adaptive sensations experienced by the subject when receiving the real stimulation treatment settings, but no effective brain modulation will be produced, which assists with blinding the participant's assignment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Craving assessed by Visual Analog Scale
Time Frame: 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.
baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression status assessed by Beck Depression Inventory (BDI)
Time Frame: 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.
baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment
Anxiety status assessed by Beck Anxiety Inventory (BAI)
Time Frame: 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.
baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment
Sleep Quality Assessment
Time Frame: 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).
baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment
Brain oscillations
Time Frame: 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.
baseline，within 30 minutes before and after each session of treatment
Reward learning
Time Frame: 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.
baseline，0-2 days after treatment, 3 months after treatment
Spatial working memory
Time Frame: 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.
baseline，0-2 days after treatment, 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Study Director: Min Zhao, PhD, Shanghai Mental Health Center

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)

October 15, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

February 15, 2024

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZhao-014

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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