COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL (COMET-7)
15 de setembro de 2026 atualizado por: Sveti Ivan Psychiatric Hospital
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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
|
Comparador Falso: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gambling Symptom Assessment Scale (G-SAS)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gambling Urges Scale (GUS)
Prazo: 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)
Prazo: 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
Prazo: six weeks
|
the number of participants who discontinued treatment
|
six weeks
|
|
Yale-Brown Obsessive Compulsive Scale adapted for GD (PG-YBOCS)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: six weeks
|
gambling abstinence, assessed daily throughout the intervention period
|
six weeks
|
|
Beck Depression Inventory-II (BDI-II)
Prazo: 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)
Prazo: 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)
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Prazo: 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
Prazo: six weeks
|
The proportion of patients whose intervention was discontinued due to adverse events
|
six weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
1 de abril de 2027
Conclusão do estudo (Estimado)
1 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
7 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de setembro de 2026
Primeira postagem (Real)
18 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IP-2025-02
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
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