Gambling Disorder
Conditions
Keywords
High-Intensity Transcranial Alternating Current Stimulation, Gambling disorder.
Brief 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. 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.
Interventions
DEVICEHI-tACS
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.
DEVICESham 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 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.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the gambling symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of depressive symptoms | 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 | 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. |
| Change of anxiety symptoms | 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 | 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. |
| Change of the sleep quality | 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 | 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. |
| Change of the gambling craving | 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 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. |
| Side effect of the modulation | Immediately after the intervention | 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. |
| Change of the self-control ability | 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 | Self-control ability will be measured by the Self-Control Scale (SCS). Higher scores of SCS indicate better self-regulation and impulse control. |
| Change of the gambling symptom severity | 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 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. |
| Change of the risky decision-making performance | Baseline, immediately after the intervention. | 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. |
| Change of the inhibitory control performance | Baseline, immediately after the intervention. | 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. |
| Change of the resting state neural activity. | Baseline, immediately after the intervention. | 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. |
Countries
China
Contacts
CONTACTJiang Du, MD, PhD.
Outcome results
None listed