COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Gambling Symptom Assessment Scale (G-SAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
30 patients who will receive active r-TMS treatment
干预措施: active r-TMS (Device)
30 patients who will receive sham r-TMS treatment
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
Gambling Symptom Assessment Scale (G-SAS)
时间窗: 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.
次要结局
- 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)
- Problem Gambling Severity Index (PGSI)(six weeks)
- gambling abstinence(six weeks)
- Beck Depression Inventory-II (BDI-II)(six weeks)
- Beck Anxiety Inventory (BAI)(six weeks)
- Quality of Life Inventory (QOLI)(six weeks)