COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL

NCT07828782 | Not Yet Recruiting

• 1 other identifier: IP-2025-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gambling Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  six weeks

Secondary Outcomes (10)

• Gambling Urges Scale (GUS)

  six weeks

• Visual Analog Scale (VAS)

  six weeks

• drop-outs

  six weeks

• Yale-Brown Obsessive Compulsive Scale adapted for GD (PG-YBOCS)

  six weeks

• South Oaks Gambling Screen (SOGS)

  six weeks

Other Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  six weeks

• Discontinuation of the treatment due to adverse events

  six weeks

Study Arms (2)

30 patients who will receive active r-TMS treatment

ACTIVE COMPARATOR

Device: active r-TMS

30 patients who will receive sham r-TMS treatment

SHAM COMPARATOR

Device: Sham (No Treatment)

Interventions

active r-TMS DEVICE

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.

30 patients who will receive active r-TMS treatment

Sham (No Treatment) DEVICE

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.

30 patients who will receive sham r-TMS treatment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• confirmed GD diagnosis according to ICD-10 (F63.0)
• age between 18 and 64 years
• male gender
• right-hand dominance

You may not qualify if:

• diagnosis of a schizophrenia spectrum disorder (ICD-10, F20-F29)
• current suicidality
• clinically relevant neurological disorder or history of cerebrovascular insult
• diagnosis of a mental and behavioral disorder due to the use of psychoactive substances (ICD-10, F10-F19) (except nicotine dependence)
• diagnosed moderate or severe dementia
• presence of intracranial implants
• inability to independently complete questionnaires
• refusal to participate due to discomfort during DLPFC localization

Sponsors & Collaborators

• Sveti Ivan Psychiatric Hospital: lead

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09