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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：30 patients who will receive active r-TMS 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.
|
|
偽コンパレータ：30 patients who will receive sham r-TMS 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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gambling Symptom Assessment Scale (G-SAS)
時間枠：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.
|
six weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gambling Urges Scale (GUS)
時間枠：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.
|
six weeks
|
|
Visual Analog Scale (VAS)
時間枠：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).
|
six weeks
|
|
drop-outs
時間枠：six weeks
|
the number of participants who discontinued treatment
|
six weeks
|
|
Yale-Brown Obsessive Compulsive Scale adapted for GD (PG-YBOCS)
時間枠：six weeks
|
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.
|
six weeks
|
|
South Oaks Gambling Screen (SOGS)
時間枠：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.
|
six weeks
|
|
Problem Gambling Severity Index (PGSI)
時間枠：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.
|
six weeks
|
|
gambling abstinence
時間枠：six weeks
|
gambling abstinence, assessed daily throughout the intervention period
|
six weeks
|
|
Beck Depression Inventory-II (BDI-II)
時間枠：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
|
|
Beck Anxiety Inventory (BAI)
時間枠：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.
|
six weeks
|
|
Quality of Life Inventory (QOLI)
時間枠：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).
|
six weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
時間枠：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)
|
six weeks
|
|
Discontinuation of the treatment due to adverse events
時間枠：six weeks
|
The proportion of patients whose intervention was discontinued due to adverse events
|
six weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IP-2025-02
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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