An interventional study of active r-TMS and Sham (No Treatment) in Gambling Disorder, sponsored by Sveti Ivan Psychiatric Hospital. Not yet recruiting. Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Sveti Ivan Psychiatric Hospital · Not applicable, Interventional, and Treatment
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.
158 studies on the registry are indexed under Gambling; 42 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 128 interventional studies indexed under Gambling.
Browse Gambling studies →Sveti Ivan Psychiatric Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: active r-TMS
Device: Sham (No Treatment)
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.
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.
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.
Time frame: six weeks
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.
Time frame: six weeks
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).
Time frame: six weeks
drop-outs
the number of participants who discontinued treatment
Time frame: six weeks
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.
Time frame: six weeks
South Oaks Gambling Screen (SOGS)
Reduction in GD severity, assessed through changes in total scores on the South Oaks Gambling Screen (SOGS), the most widely used instrument for evaluating GD severity. It is a 20-item questionnaire used to screen for problem gambling and pathological gambling behaviors. It contains multiple informational questions, and each "at-risk" answer earns 1 point.
Time frame: six weeks
Problem Gambling Severity Index (PGSI)
Problem Gambling Severity Index (PGSI) is a widely recognized, standardized 9-item self-report questionnaire used to assess the severity of gambling behaviors and their negative consequences. Each question is scored on a 4-point scale (0 = Never; 1 = Sometimes; 2 = Often; 3 = Almost always / Always), yielding a total score from 0 to 27.
Time frame: six weeks
gambling abstinence
gambling abstinence, assessed daily throughout the intervention period
Time frame: six weeks
Beck Depression Inventory-II (BDI-II)
Reduction in depressive symptoms, measured using the Beck Depression Inventory-II (BDI-II). It is a widely used 21-item self-report questionnaire designed to measure the severity of depressive symptoms. Each item is scored on a 4-point Likert scale ranging from 0 to 3, where higher numbers reflect greater symptom intensity.
Time frame: six weeks
Beck Anxiety Inventory (BAI)
Reduction in anxiety symptoms, assessed using the Beck Anxiety Inventory (BAI). It is a 21-item self-report questionnaire used to measure the severity of an adult or adolescent's anxiety symptoms over the past week. It contains questions rated on a 4-point scale from 0 to 3, and greater scores means greater anxiety.
Time frame: six weeks
Quality of Life Inventory (QOLI)
Improvement in quality of life, measured using the Quality of Life Inventory (QOLI), the most frequently used tool for assessing quality-of-life. It measures an individual's happiness and life satisfaction across 16 key areas. It consists of 32 items measuring both the importance of each domain (on a 3-point scale) and current satisfaction with it (on a 6-point scale).
Time frame: six weeks
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)
Time frame: six weeks
Discontinuation of the treatment due to adverse events
The proportion of patients whose intervention was discontinued due to adverse events
Time frame: six weeks
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 6 months is below that.
Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Sveti Ivan Psychiatric Hospital