An interventional study of HI-tACS and Sham stimulation in Gambling Disorder, sponsored by Shanghai Mental Health Center. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment
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.
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.
158 studies on the registry are indexed under Gambling; 42 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 128 interventional studies indexed under Gambling.
Browse Gambling studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: HI-tACS
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.
Device: Sham stimulation
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.
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.
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.
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 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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, immediately after the intervention.
Individualized Electric Field Simulation and Dose Estimation
Structural magnetic resonance imaging (sMRI) with T1-weighted imaging, along with diffusion tensor imaging (DTI), will be employed to construct individualized head models for simulating the electric field distribution of HI-tACS. This approach will allow us to estimate the individualized stimulation intensity and assess the optimal dose for each participant.
Time frame: Baseline, immediately after the intervention.
Change of the molecular-level neurochemistry
SPICE fast spectroscopic imaging will be employed to measure molecular-level neurochemical metabolites. This technique enables simultaneous acquisition of spatial distribution and concentration changes of multiple metabolites and neurotransmitter-related indicators within a single clinically acceptable scan time, allowing for assessment of brain molecular metabolic spectrum remodeling before and after the intervention.
Time frame: Baseline, immediately after the intervention.
Plan to share: No
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Start is estimated for Jun 2026; primary completion for Nov 2026, 5 months later.
Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 5 months is below that.
Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.
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