Study of the Effect of an Active rTMS Session in Pathological Gamblers: Impact on Craving and Severity of These Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Assessing cue-induced craving
研究概览
简要总结
The gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. Currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs.
In pathological gambling and addictions, craving (or urge to play) and loss of control are two essential clinical elements. The neurobiological level, they are associated with a dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and Goldstein, 2002).
One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation (rTMS).
详细描述
Patients included in this study will have:
- An anatomical brain MRI (30 minutes).
- Two 20 minute sessions of rTMS (placebo and active) of the left DLPFC, at the frequency of 10 Hz.
- Visual Analogue Scale measuring their desire to gamble before and after a gambling video and test measuring their gambling behavior during the last 7 days (PG-YBOCS).
- Cognitive tests, to be carried out on a computer before and immediately after rTMS sessions.
- Recording heart rate variability (HRV) to measure the autonomic nervous system (ANS) activity
As it is a pilot study, the investigators don't have sufficient data to calculate statistical power and number of participants. The investigators based on previous studies evaluating one rTMS session on craving in SUD and used a crossover design to generate greater power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of pathological gambling (DSM IV criteria)
- •First-time consultants.
- •Without psychotropic treatment or treatment with a stable and unchanged for over a month.
排除标准
- •Presence of ferromagnetic material or devices implanted neurostimulation in close contact with the coil
- •Pregnant women and patients with hearing disorders
- •Personal history of epilepsy (untreated or poorly balanced)
- •Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
- •History of head trauma with loss of consciousness,
- •Administration of drugs or substances lowering the seizure threshold
- •Sleep deprivation, jet lag, or drug withdrawal.
- •Participants with a problem of uncorrected visual acuity.
- •Other current addiction (except tobacco, for reasons of feasibility).
- •Current Psychiatric comorbidity
- •Treatment psychotropic introduced or changed for less than a month.
- •Subjects with atrial fibrillation, with a pacemaker and / or receiving antiarrhythmic drugs
研究组 & 干预措施
rTMS active then rTMS placebo
A 20 minute session of rTMS active at the frequency of 10 Hz then, 7 days later, a 20 minute session of rTMS placebo (rTMS active then rTMS placebo).
Patient will also have cognitive tests before and after rTMS session and HRV recording during visit.
干预措施: rTMS active then rTMS placebo (Device)
rTMS placebo then rTMS active
A 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS active at the frequency of 10 Hz (rTMS placebo then rTMS active).
Patient will also have cognitive tests before and after rTMS session and HRV recording during visit
干预措施: rTMS placebo then rTMS active (Device)
结局指标
主要结局
Assessing cue-induced craving
时间窗: After the session of rTMS (Day 2)
Scores on visual analog scales assessing craving just after a gambling video
次要结局
- Game behavior(Day 2)
- Cognitive tests(Day 2)
- ANS activity(Day 2)