Amphetamine-Related DisordersNCT06145698
Treatment Effect of Cross-frequency Transcranial Alternating Current Stimulation on the MUD
A study testing Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device in people with Amphetamine-Related Disorders, run by Shanghai Mental Health Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Amphetamine-Related Disorders
- What is being tested?
- Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- Normal vision and hearing
- Dextromanual
- Use MA not less than 1 year, and the last of MA use no less than 3 months
Who cannot join
- Have a disease that affects cognitive function such as a history of head injury, cerebrovascular disease, epilepsy, etc
- Have cognitive-promoting drugs in the last 6 months
- Other substance abuse or dependence in recent five years (except nicotine)
- Meet the DSM-5 criteria for other mental disorders
- Physical disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Compulsory Rehabilitation Center
Wuhan, 430000
Hang Su
About this study
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
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.
Read the 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.
- Conditions
- Amphetamine-Related Disorders
- Being tested
- Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: theta-gamma tACS | Experimental | 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. Receives: Device: Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device |
| Active-sham tACS | Sham comparator | 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. Receives: Device: Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment
Secondary outcomes (6)
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.
Measured: baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment
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.
Measured: baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment
Sleep Quality Assessment
Sleep Quality is assessed by the scores of Insomnia Severity Index(ISI) and Pittsburgh Sleep Quality Index(PSQI).
Measured: baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment
Brain oscillations
Assessed by Resting EEG task under the electroencephalogram recording to extract alpha, beta, theta, and gamma band energy.
Measured: baseline，within 30 minutes before and after each session of treatment
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.
Measured: baseline，0-2 days after treatment, 3 months after treatment
Spatial working memory
Working memory capacity is assessed by Spatial working memory under the electroencephalogram recording. The indicator is the correctness and response time.
Measured: baseline，0-2 days after treatment, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start15 Oct 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine-Related DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, PhD, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145698
- Sponsor's protocol ID
- MZhao-014
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06145698
- Acronym / sponsor ID
- MZhao-014
- Conditions
- Amphetamine-Related Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: theta-gamma tACS | Experimental | Device: Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation deviceThe 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. |
| Active-sham tACS | Sham comparator | Device: Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation deviceFor 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- Normal vision and hearing
- Dextromanual
- Use MA not less than 1 year, and the last of MA use no less than 3 months
Key exclusion criteria (5 listed)
- Have a disease that affects cognitive function such as a history of head injury, cerebrovascular disease, epilepsy, etc
- Have cognitive-promoting drugs in the last 6 months
- Other substance abuse or dependence in recent five years (except nicotine)
- Meet the DSM-5 criteria for other mental disorders
- Physical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation deviceStimulation 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. | Device | Active-sham tACS, Experimental: theta-gamma tACS |
Primary outcome
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.
6 secondary outcomes
Depression status assessed by Beck Depression Inventory (BDI)
Time frame: 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
Sleep Quality Assessment
Time frame: 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
Reward learning
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Zhao, PhD study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device in people with Amphetamine-Related Disorders, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Zhao, PhD (021-54252689, 18017311005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Craving assessed by Visual Analog Scale (time frame: baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.