Effect of High-Intensity Transcranial Alternating Current Stimulation on Gambling Disorder: A Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • HI-tACS

    Device

    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 stimulation

    Device

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention group for gambling disorderExperimental treatment 1 intervention
Group B: Sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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.
2

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.

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