Substance DependenceNCT05312359
Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents
A study testing Transcranial alternating current stimulation-true stimulus in people with Substance Dependence and Executive Function Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The investigators assume that tACS could improve amphetamine and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Dependence, Executive Function Disorder, Transcranial Alternating Current Stimulation
- What is being tested?
- Transcranial alternating current stimulation-true stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests
- Meet DSM-5 diagnostic criteria for amphetamine-type substance addiction or alcohol addiction
- Have used amphetamine or alcohol for at least one year (at least once a week)
- Normal vision and hearing, or within the normal range after correction
- Agree to cooperate in the follow-up evaluation
- No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity
Who cannot join
- Have severe cognitive impairment, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
- Have used drugs promoting cognitive function in the last 6 months
- Have impaired intelligence (IQ<70)
- Abuse or dependence of other psychoactive substances (except nicotine) in the last 5 years
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Brain Mechanism and Intervention of Executive-control Dysfunction Caused by Impaired Prefrontal-ventral Striatum Synchronization Among Substance Dependents
The investigators assume that tACS could improve amphetamine and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.
Read the detailed description
Substance abuse has become a major social and public health problem in China, especially for amphetamine abuse and alcohol abuse. Executive-control dysfunction is the main symptom for substance dependents. Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognitive, and tACS could improve executive-control function by adjusting the abnormal synchronization. But it has not been verified among MA or alcohol patients. The investigators assume that tACS could improve MA and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for substance dependents.
- Conditions
- Substance Dependence, Executive Function Disorder, Transcranial Alternating Current Stimulation
- Being tested
- Transcranial alternating current stimulation-true stimulus, Transcranial alternating current stimulation-sham stimulus
- Keywords
- Substance dependence, Execution-control dysfunction, Synchronization, Transcranial alternating current stimulation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating current stimulation-true stimulusDevice
The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively. Before the intervention, the individual alpha frequency (IAF) of the subjects was measured according to the average peak value of α waves at dorsolateral prefrontal cortex in the closed state. Then an alternating current at θ frequency (θ = IAF - 5Hz) was applied to each subject based on its IAF value. The amplitude of stimulation was increased with a step of 20μA starting from 0. When the subjects had a slight prickling sensation or optical illusion, the stimulation current was decreased with a step of 20μA until the sensation disappeared. The current value at this time was used as the stimulation current of the subjects.
Transcranial alternating current stimulation-sham stimulusDevice
The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively. The actual stimulation waveform was just implemented in the first 60 s (or more longer) and then faded out.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | No intervention | No intervention is conducted in the healthy control group. |
| Intervention group of amphetamine addiction | Experimental | A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of amphetamine addiction. Receives: Device: Transcranial alternating current stimulation-true stimulus |
| Control group of amphetamine addiction | Sham comparator | A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of amphetamine addiction. Receives: Device: Transcranial alternating current stimulation-sham stimulus |
| Intervention group of alcohol addiction | Experimental | A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of alcohol addiction. Receives: Device: Transcranial alternating current stimulation-true stimulus |
| Control group of alcohol addiction | Sham comparator | A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of alcohol addiction. Receives: Device: Transcranial alternating current stimulation-sham stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of inhibitory control ability
The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.
Measured: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
The change of theta(θ) phase synchronicity
The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
Measured: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
The change of theta-gamma phase amplitude coupling(θ-γ PAC)
The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
Measured: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Secondary outcomes (3)
The change of working memory
The change of working memory will be measured by the two-back task.
Measured: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
DA metabolic rate
DA metabolism was measured by Positron Emission Computed Tomography
Measured: baseline
The change of decision-making ability
The change of decision-making ability will be measured by the Balloon Analog Risk Task.
Measured: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance DependenceStudies 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312359
- Sponsor's protocol ID
- JDu-010
- Status last verified
- Jan 2022
- First submitted
- 5 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanism and Intervention of Executive-control Dysfunction Caused by Impaired Prefrontal-ventral Striatum Synchronization Among Substance Dependents
- ClinicalTrials.gov ID
- NCT05312359
- Acronym / sponsor ID
- JDu-010
- Conditions
- Substance Dependence, Executive Function Disorder, Transcranial Alternating Current Stimulation
- Keywords
- Substance dependence, Execution-control dysfunction, Synchronization, Transcranial alternating current stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Apr 2022 (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 investigators assume that tACS could improve amphetamine and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.
Detailed description
Substance abuse has become a major social and public health problem in China, especially for amphetamine abuse and alcohol abuse. Executive-control dysfunction is the main symptom for substance dependents. Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognitive, and tACS could improve executive-control function by adjusting the abnormal synchronization. But it has not been verified among MA or alcohol patients. The investigators assume that tACS could improve MA and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for substance dependents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | No intervention | –No intervention is conducted in the healthy control group. |
| Intervention group of amphetamine addiction | Experimental | Device: Transcranial alternating current stimulation-true stimulusA 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of amphetamine addiction. |
| Control group of amphetamine addiction | Sham comparator | Device: Transcranial alternating current stimulation-sham stimulusA 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of amphetamine addiction. |
| Intervention group of alcohol addiction | Experimental | Device: Transcranial alternating current stimulation-true stimulusA 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of alcohol addiction. |
| Control group of alcohol addiction | Sham comparator | Device: Transcranial alternating current stimulation-sham stimulusA 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of alcohol addiction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests
- Meet DSM-5 diagnostic criteria for amphetamine-type substance addiction or alcohol addiction
- Have used amphetamine or alcohol for at least one year (at least once a week)
- Normal vision and hearing, or within the normal range after correction
- Agree to cooperate in the follow-up evaluation
Key exclusion criteria (4 listed)
- Have severe cognitive impairment, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
- Have used drugs promoting cognitive function in the last 6 months
- Have impaired intelligence (IQ<70)
- Abuse or dependence of other psychoactive substances (except nicotine) in the last 5 years
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 |
|---|---|---|
| Transcranial alternating current stimulation-true stimulusThe adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively. Before the intervention, the individual alpha frequency (IAF) of the subjects was measured according to the average peak value of α waves at dorsolateral prefrontal cortex in the closed state. Then an alternating current at θ frequency (θ = IAF - 5Hz) was applied to each subject based on its IAF value. The amplitude of stimulation was increased with a step of 20μA starting from 0. When the subjects had a slight prickling sensation or optical illusion, the stimulation current was decreased with a step of 20μA until the sensation disappeared. The current value at this time was used as the stimulation current of the subjects. | Device | Intervention group of alcohol addiction, Intervention group of amphetamine addiction |
| Transcranial alternating current stimulation-sham stimulusThe adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively. The actual stimulation waveform was just implemented in the first 60 s (or more longer) and then faded out. | Device | Control group of alcohol addiction, Control group of amphetamine addiction |
Primary outcome
The change of inhibitory control ability
Time frame: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.
The change of theta(θ) phase synchronicity
Time frame: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
The change of theta-gamma phase amplitude coupling(θ-γ PAC)
Time frame: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
3 secondary outcomes
The change of working memory
Time frame: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
DA metabolic rate
Time frame: baseline
The change of decision-making ability
Time frame: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulation-true stimulus in people with Substance Dependence and Executive Function Disorder, 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 6 inclusion and 4 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 5 Apr 2022. 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 Jiang Du (021-64906315, dujiangdou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of inhibitory control ability (time frame: baseline, immediately after the intervention, one month after the intervention, three months after the intervention). The study lists 3 primary outcomes in all. 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 5 Apr 2022.