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COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL
Sponsor: Sveti Ivan Psychiatric Hospital
Summary
This study aims to investigate whether a treatment called high-frequency repetitive transcranial magnetic stimulation (rTMS) can help reduce the symptoms of gambling disorder and whether it is safe and well tolerated. The study will include 60 men aged 18-64 years who have been diagnosed with gambling disorder and are starting treatment at the Gambling Disorder Day Hospital of UPC Sveti Ivan in Zagreb. Participants will be randomly assigned to one of two groups. One group will receive active rTMS treatment using the H7 coil, while the other group will receive a sham (placebo) treatment that looks and feels similar but does not provide the active magnetic stimulation. Neither the participants nor the researchers assessing the results will know which treatment each participant received during the study. All participants will continue to receive their usual treatment. The study will last six weeks. Participants will complete questionnaires before treatment and six weeks after the intervention. The main goal is to determine whether rTMS reduces the severity of gambling-related symptoms. The researchers will also examine whether personal, psychological, and clinical characteristics can help predict who is most likely to benefit from rTMS. In addition, the study will investigate whether rTMS affects autonomic nervous system regulation, measured through heart rate variability (HRV), and will assess the economic impact of this treatment. Overall, the study is intended to provide better information about the effectiveness, safety, possible predictors of treatment response, effects on the body's regulation, and cost-effectiveness of rTMS for gambling disorder.
Key Details
Gender
MALE
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-10
Completion Date
2027-12
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
active r-TMS
The intervention will involve rTMS treatment using the H7 coil (Brainsway Ltd., Jerusalem, Israel) with the following parameters: Magnetic field intensity: 100% of the observed motor threshold, frequency: 20 Hz, stimulation duration: 2 seconds, pause between stimulations: 20 seconds, number of stimulations: 50, number of magnetic pulses per session: 2,000, session duration: ≈18 minutes, total intervention duration: one session per day, five days per week, for five weeks, followed by one session per day for four days in the sixth week, total number of pulses: 58,000.
Sham (No Treatment)
The control group will receive sham rTMS using an H7 coil (Brainsway Ltd., Jerusalem, Israel), administered identically to active rTMS treatment. The sham coil is positioned above the active coil within the device, ensuring that its shape, pulsing sound, and subjective sensation of stimulation are indistinguishable from the active rTMS coil, but without generating electromagnetic induction.