Gambling DisorderHITACSRCT-GDNCT07228182
Effect of High-Intensity Transcranial Alternating Current Stimulation on Gambling Disorder: A Randomized Controlled Trial
A study testing HI-tACS in people with Gambling Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The investigators assume that High-intensity transcranial Alternating Current Stimulation (HI-tACS) could improve gambling disorder patients' executive-control function by modulating abnormal neural activity, particularly gamma-band oscillations, which are closely associated with executive-control deficits. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- HI-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 28 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 and Statistical Manual of mental disorders，DSM) diagnostic criteria for gambling disorder;
- Have gambled 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 (Intelligence Quotient<70);
- Abuse or dependence of psychoactive substances (except nicotine) in the last 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Jiang Du, MD, PhD., +86 021 6490 6315, dujiangdou@163.com
About this study
The investigators assume that High-intensity transcranial Alternating Current Stimulation (HI-tACS) could improve gambling disorder patients' executive-control function by modulating abnormal neural activity, particularly gamma-band oscillations, which are closely associated with executive-control deficits. This study intends to validate the effect of HI-tACS treatment, which has been discovered in the previous pilot study. A three-month follow-up assessment will be conducted to test the changes in executive-control function and its underlying mechanism.
Read the detailed description
Gambling disorder has become a major social and public health problem in China. Executive-control dysfunction is the main symptom of behavioral addictions such as gambling disorder. Previous studies have demonstrated that abnormal neural activity is distributed across multiple brain regions and networks throughout the whole brain. Research has shown that abnormal neural activity, particularly in the gamma band, contributes to executive-control deficits. High-intensity transcranial Alternating Current Stimulation (HI-tACS) has been found to improve executive-control function by modulating this abnormal gamma-band activity. However, this has not yet been verified in gambling disorder patients. The investigators assume that HI-tACS could improve gambling disorder patients' executive-control function by modulating abnormal gamma-band neural activity, which is closely associated with executive-control deficits. This study intends to test the effect of HI-tACS treatment, which was discovered in a previous pilot study. A three-month follow-up assessment will be conducted to examine changes in executive-control function and its underlying mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for gambling disorder.
- Conditions
- Gambling Disorder
- Being tested
- HI-tACS, Sham stimulation
- Keywords
- High-Intensity Transcranial Alternating Current Stimulation, Gambling disorder.
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HI-tACSDevice
Three conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. The frequency of stimulation is 77.5Hz, and the current is 15mA.
Sham stimulationDevice
Three conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The appearance of the above-mentioned equipment is identical to that of the real stimulation group devices, but it only simulates the electrical sensation produced at the beginning and end of stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group for gambling disorder | Experimental | A 40-minute transcranial alternating current stimulus intervention of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling disorder. Receives: Device: HI-tACS |
| Sham stimulation | Sham comparator | A 40-minute transcranial alternating current stimulus intervention of sham stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling disorder. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the gambling symptoms
Gambling symptom severity will be measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS). The total score of PG-YBOCS ranges from 0 to 40, in which higher scores indicate more severe pathological gambling symptoms.
Measured: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Secondary outcomes (10)
Change of depressive symptoms
Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale (HAMD-17). The total score of HAMD-17 ranges from 0 to 52, in which higher scores mean a higher severity of depressive symptoms.
Measured: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of anxiety symptoms
Anxiety symptoms will be measured by the 14-item Hamilton Anxiety Rating Scale (HAMA-14). The total score of HAMA-14 ranges from 0 to 56, in which higher scores mean a higher severity of anxiety symptoms.
Measured: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of the sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). The total score of PSQI ranges from 0 to 21, in which higher scores mean poorer sleep quality.
Measured: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of the gambling craving
Gambling craving will be measured by the gambling craving Visual Analog Scale (VAS). The total score of VAS ranges from 0 to 10, in which higher scores mean a higher level of gambling craving.
Measured: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Side effect of the modulation
Side effects will be assessed using a standardized adverse reaction evaluation form. The total score varies depending on symptom severity, with higher scores indicating more significant adverse reactions.
Measured: Immediately after the intervention
Change of the self-control ability
Self-control ability will be measured by the Self-Control Scale (SCS). Higher scores of SCS indicate better self-regulation and impulse control.
Measured: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of the gambling symptom severity
Gambling symptom severity will be measured by the Gambling Symptom Assessment Scale (G-SAS). The total score of G-SAS ranges from 0 to 48, in which higher scores mean more severe gambling-related symptoms.
Measured: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of the risky decision-making performance
Risky decision-making performance will be assessed using the Balloon Analogue Risk Task (BART). Higher average pumps in the BART indicate greater risk-taking propensity. Electroencephalography (EEG) will be used to measure neural electrical signals, where increases in relevant electrophysiological indicators may reflect heightened individual sensitivity to negative feedback.
Pig dice game will be administered during functional magnetic resonance imaging (fMRI) scanning to assess risk-taking decision-making. Higher frequency of continued dice rolls indicates greater risk propensity. Neural activity features related to the task will be analyzed, with specific patterns associated with risk evaluation and reward processing.
Measured: Baseline, immediately after the intervention.
Change of the inhibitory control performance
The stop-signal task (SST) will be employed to measure inhibitory control, with longer stop-signal reaction times (SSRT) indicating poorer response inhibition. Concurrent EEG recording will be performed, and changes in relevant electrophysiological indicators can serve as electrophysiological markers of increased cognitive conflict and reduced inhibitory processing efficiency.
Measured: Baseline, immediately after the intervention.
Change of the resting state neural activity.
Resting-state functional magnetic resonance imaging (rsfMRI) will be used to assess intrinsic brain connectivity. Resting-state electroencephalography (rsEEG) will be employed to measure spontaneous neural oscillations.
Measured: Baseline, immediately 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 posted14 Nov 2025
- Study start1 Jun 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT07228182
- Sponsor's protocol ID
- JDu-017
- Acronym
- HITACSRCT-GD
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Transcranial Alternating Current Stimulation on Gambling Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07228182
- Acronym / sponsor ID
- HITACSRCT-GD / JDu-017
- Conditions
- Gambling Disorder
- Keywords
- High-Intensity Transcranial Alternating Current Stimulation, Gambling disorder.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 14 Nov 2025 (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 High-intensity transcranial Alternating Current Stimulation (HI-tACS) could improve gambling disorder patients' executive-control function by modulating abnormal neural activity, particularly gamma-band oscillations, which are closely associated with executive-control deficits. This study intends to validate the effect of HI-tACS treatment, which has been discovered in the previous pilot study. A three-month follow-up assessment will be conducted to test the changes in executive-control function and its underlying mechanism.
Detailed description
Gambling disorder has become a major social and public health problem in China. Executive-control dysfunction is the main symptom of behavioral addictions such as gambling disorder. Previous studies have demonstrated that abnormal neural activity is distributed across multiple brain regions and networks throughout the whole brain. Research has shown that abnormal neural activity, particularly in the gamma band, contributes to executive-control deficits. High-intensity transcranial Alternating Current Stimulation (HI-tACS) has been found to improve executive-control function by modulating this abnormal gamma-band activity. However, this has not yet been verified in gambling disorder patients. The investigators assume that HI-tACS could improve gambling disorder patients' executive-control function by modulating abnormal gamma-band neural activity, which is closely associated with executive-control deficits. This study intends to test the effect of HI-tACS treatment, which was discovered in a previous pilot study. A three-month follow-up assessment will be conducted to examine changes in executive-control function and its underlying mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for gambling disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group for gambling disorder | Experimental | Device: HI-tACSA 40-minute transcranial alternating current stimulus intervention of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling disorder. |
| Sham stimulation | Sham comparator | Device: Sham stimulationA 40-minute transcranial alternating current stimulus intervention of sham stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling disorder. |
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 and Statistical Manual of mental disorders，DSM) diagnostic criteria for gambling disorder;
- Have gambled 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 (Intelligence Quotient<70);
- Abuse or dependence of 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 |
|---|---|---|
| HI-tACSThree conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. The frequency of stimulation is 77.5Hz, and the current is 15mA. | Device | Intervention group for gambling disorder |
| Sham stimulationThree conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The appearance of the above-mentioned equipment is identical to that of the real stimulation group devices, but it only simulates the electrical sensation produced at the beginning and end of stimulation. | Device | Sham stimulation |
Primary outcome
Change of the gambling symptoms
Time frame: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Gambling symptom severity will be measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS). The total score of PG-YBOCS ranges from 0 to 40, in which higher scores indicate more severe pathological gambling symptoms.
10 secondary outcomes
Change of depressive symptoms
Time frame: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of anxiety symptoms
Time frame: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of the sleep quality
Time frame: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of the gambling craving
Time frame: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Side effect of the modulation
Time frame: Immediately after the intervention
Change of the self-control ability
Time frame: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of the gambling symptom severity
Time frame: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Change of the risky decision-making performance
Time frame: Baseline, immediately after the intervention.
Change of the inhibitory control performance
Time frame: Baseline, immediately after the intervention.
Change of the resting state neural activity.
Time frame: Baseline, immediately after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HI-tACS in people with Gambling 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang Du, MD, PhD. (+8602164906315, dujiangdou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the gambling symptoms (time frame: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention). 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 10 Jun 2026.