The investigators assume that transcranial Alternating Current Stimulation (tACS) could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to validate the effect of tACS treatment, which has been discovered in the previous pilot study. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism.
Gambling disorder is become a major social and public health problem in China. Executive-control dysfunction is the main symptom of behavioral addiction like gambling disorder. 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 cognition, and transcranial Alternating Current Stimulation (tACS) could improve executive-control function by adjusting the abnormal synchronization. However, it has not been verified among gambling disorder patients. The investigators assume that tACS could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to test the effect of tACS treatment, which has been discovered in the previous pilot study. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for gambling disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
Shanghai Mental Health Center
Shanghai, China
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 measured by the Treatment Emergent Symptom Scale (TESS). The total score of TESS varies depending on symptom severity, in which higher scores indicate 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. Feedback-related negativity (FRN) will be recorded using electroencephalography (EEG), with larger amplitude typically reflecting enhanced 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 in the prefrontal cortex and striatum will be analyzed, with increased activation typically associated with risk evaluation and reward processing.
Time frame: Baseline, two weeks after the intervention.
Change of the inhibitory control performance
Stop-signal task (SST) will be employed to measure inhibitory control. Longer stop-signal reaction times (SSRT) indicate poorer response inhibition. The N2/P3 components will be recorded using electroencephalography (EEG), with enhanced N2 amplitude and reduced P3 amplitude typically reflecting greater cognitive conflict and inhibitory processing efficiency, respectively.
Time frame: Baseline, two weeks 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. Lower amplitude of low-frequency fluctuations (ALFF) and reduced functional connectivity (FC) within the default mode network (DMN) may reflect altered neural efficiency. Resting-state electroencephalography (rsEEG) will be employed to measure spontaneous neural oscillations. Enhanced theta/beta ratio and reduced alpha power may indicate compromised regulatory control and cortical arousal, respectively.
Time frame: Baseline, two weeks after the intervention.
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