COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL (COMET-7)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
- right-hand dominance
Exclusion Criteria:
- 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
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 30 patients who will receive active r-TMS treatment
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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.
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가짜 비교기: 30 patients who will receive sham r-TMS treatment
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gambling Symptom Assessment Scale (G-SAS)
기간: six weeks
|
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.
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six weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gambling Urges Scale (GUS)
기간: six weeks
|
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.
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six weeks
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Visual Analog Scale (VAS)
기간: six weeks
|
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).
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six weeks
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drop-outs
기간: six weeks
|
the number of participants who discontinued treatment
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six weeks
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Yale-Brown Obsessive Compulsive Scale adapted for GD (PG-YBOCS)
기간: six weeks
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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.
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six weeks
|
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South Oaks Gambling Screen (SOGS)
기간: six weeks
|
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.
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six weeks
|
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Problem Gambling Severity Index (PGSI)
기간: six weeks
|
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.
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six weeks
|
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gambling abstinence
기간: six weeks
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gambling abstinence, assessed daily throughout the intervention period
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six weeks
|
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Beck Depression Inventory-II (BDI-II)
기간: six weeks
|
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.
|
six weeks
|
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Beck Anxiety Inventory (BAI)
기간: six weeks
|
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.
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six weeks
|
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Quality of Life Inventory (QOLI)
기간: six weeks
|
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).
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six weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
기간: six weeks
|
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)
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six weeks
|
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Discontinuation of the treatment due to adverse events
기간: six weeks
|
The proportion of patients whose intervention was discontinued due to adverse events
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six weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IP-2025-02
약물 및 장치 정보, 연구 문서
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