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.
confirmed GD diagnosis according to ICD-10 (F63.0)
age between 18 and 64 years
male gender
enrolled in GD treatment at the GD-DH of the UPC Sveti Ivan within two weeks of study inclusion.
diagnosis of a schizophrenia spectrum disorder (ICD-10, F20-F29)
diagnosed psychotic episode within six months prior to inclusion
current suicidality
clinically relevant neurological disorder or history of cerebrovascular insult
Parallel
active r-TMS
DeviceThe 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)
DeviceThe 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.
Gambling Symptom Assessment Scale (G-SAS)
The primary outcome will be the change in the severity of gambling disorder (GD), measured using the Gambling Symptom Assessment Scale (G-SAS), the most commonly used scale for assessing changes in GD symptom severity in research studies. Each item on the G-SAS is rated on a 5-point scale, ranging from 0 (no symptoms) to 4 (extreme symptoms). The total score can range from 0 to 48. Higher scores indicate greater severity of gambling-related symptoms.
Gambling Urges Scale (GUS)
The Gambling Urge Scale (GUS) is a 6-item questionnaire designed to measure an individual's current urge or craving to gamble, on a 7-point scale. Responses are summed for a total score; higher scores reflect stronger immediate cravings or urges to gamble.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a continuous measurement instrument used to quantify subjective internal experiences of pain. It consists of a line with word descriptors placed at opposite extremes ("No pain" at 0 mm and "Worst pain imaginable" at 100 mm).
drop-outs
the number of participants who discontinued treatment
Yale-Brown Obsessive Compulsive Scale adapted for GD (PG-YBOCS)
Reduction in the severity of obsessive-compulsive symptoms related to GD, measured using the Yale-Brown Obsessive Compulsive Scale adapted for GD (PG-YBOCS). The scale evaluates the intensity, frequency, and impact of gambling urges, thoughts, and behaviors. It features 10 items scored from 0 to 4, yielding a total score from 0 to 40.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
The incidence of adverse events, including headache, neck pain, scalp discomfort, tingling, burning sensations, skin redness, drowsiness, sleep disturbances, back pain, difficulty concentrating, acute mood changes, hearing impairment, facial muscle spasms or twitches, dizziness, nausea, lightheadedness, or any other adverse event (self-reported and recorded by clinicians)
Discontinuation of the treatment due to adverse events
The proportion of patients whose intervention was discontinued due to adverse events
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