Deep Low-Frequency Repetitive Transcranial Magnetic Stimulation for Cessation of Pathological Gambling
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- SOGS (South Oaks Gambling Screen)
研究概览
简要总结
Pathological gambling (PG) is characterized by a persistent pattern of continued gambling behavior despite its adverse consequences. PG is a chronic, progressive, male-dominated disorder, which has a prevalence of 1% to 3.4% among US adults. Deep transcranial magnetic stimulation (TMS) is a novel neuro-stimulation method capable of inhibiting neuronal activity when given in low frequency. The hypothesis of this study is that , Pathological gambling will be ameliorated if low frequency magnetic field using Brainsway H1 coil will be applied to the left dorso-lateral prefrontal cortex of these patients.
详细描述
Deep Low-Frequency Repetitive Transcranial Magnetic Stimulation for cessation of pathological gambling
Introduction:
Pathological gambling (PG) is characterized by a persistent pattern of continued gambling behavior despite its adverse consequences. PG is a chronic, progressive, male-dominated disorder, which has a prevalence of 1% to 3.4% among US adults. Typically, the patient's life becomes dominated by the gambling behavior leading to overwhelming financial burdens, an inability to maintain a career, and to the eventual disintegration of family relationships. The enormous personal and social consequences of this disorder include a high rate of suicide attempts, legal problems, and criminal behavior [R1].
Several theoretical models of drug addiction have suggested that addiction is related to abnormal activity in the ventromedial prefrontal cortex system, which is necessary for inhibiting both the craving for immediate reward and excitement-seeking behavior [ref2]. Neuropsychological studies of pathological gamblers [ref 3to9 ref2 ref10] have demonstrated that pathological gamblers have deficits in the frontal lobe/reward system leading investigators to hypothesize that impairment of executive function may play an important role in the etiology of pathological gambling.
Drawing from the field of drug dependence, it has been speculated that the underlying pathology in pathological gambling is a reduction in the sensitivity of the reward system. Reuter et al studied pathological gamblers and controls during a guessing game using functional magnetic resonance imaging and observed a reduction of ventral striatal and ventromedial prefrontal activation in the pathological gamblers that was negatively correlated with gambling severity, linking hypo-activation of these areas to disease severity [ ref11]. Studies in the field of addiction have shown that prefrontal regulation of behavior is reduced in basal conditions, thereby contributing to the reduced salience of non-drug motivational stimuli and reduced decision-making ability. However, when stimuli predicting drug availability are presented, there is profound activation of the prefrontal cortex and glutamatergic drive to the nucleus accumbens [ref12].
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological gambling according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
排除标准
- •History of a primary major psychiatric or cognitive disorder according to DSM IV apart from Pathological gambling.
- •Current alcohol or other substance abuse or dependence.
- •Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
- •History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery.
- •Significant neurological co-morbidity.
- •psychiatric co-morbidity.
- •psychotropic medications.
- •Severe somatic co morbidity.
- •Cardiac pace makers, other electronic implants, intracranial metallic particles.
- •History of seizures or epileptiform activity.
- •Pregnancy and lactation.
- •Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the experiment.
- •Patients unwilling or unable to give written informed consent.
- •Patients with a high risk for severe violence or suicidality as assessed during the screening interview.
- •Participation in a clinical trial within the last 30 days before the beginning of this clinical trial or similar participation in another clinical trial.
结局指标
主要结局
SOGS (South Oaks Gambling Screen)
时间窗: 45 days
The South Oaks Gambling Screen is a 20-item questionnaire based on Diagnostic and Statistical Manual of Mental Disorders, Third Edition (DSM-III) criteria for pathological gambling.
Dannon Ainhold Gambling Scale
时间窗: 45 days
A scale for assessment of pathological gambling
visual analogue scale
时间窗: 45 Days
An instrument for assessment of desire to indulge in gambling
次要结局
- Hamilton Depression 24 items(45 Days)
- Hamilton Anxiety scale(45 days)
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(45 days)
- Clinical Global Impression Improvement (CGI-I)(45 days)
- Social Adaptational Scale(SAS)(45 days)