Efficiency of rTMS in Bulimia: a Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficiency of rTMS in bulimia
研究概览
简要总结
Bulimia nervosa is defined by recurrent episodes of binge eating followed by compensatory behaviors (such as induced vomiting) to prevent weight gain. It is a common and serious disease for which current treatment strategies have to be improved.
The aim of this study is to assess whether a transcranial magnetic stimulation reduces bulimic symptoms in a short term.
详细描述
Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive outpatient technique of brain stimulation, based on the delivery of the localized magnetic field. It is now widely used a in a variety of neurological and psychiatric disorders.
Several clinical and pathophysiological studies suggest efficacy of rTMS on the reduction of craving and/or addictive behavior in various addictions such as alcoholism, smocking or cocaine. Because of the addictive design of the BN, the effect of one session of rTMS on food craving has been tested.
These studies show that stimulation of left dorsolateral prefrontal cortex (DPLPFC) under high frequency decreases craving food. In addition, in a healthy subject, studies show that rTMS appear to alter neuropsychological functions very involved in physiopathology of bulimia. To date, the investigators do not know if rTMS cold be a useful treatment in the treatment of bulimia. But in the light of these data, the investigators hypothesize that a program of rtMS may have a therapeutic effect and therefore an interest for the treatment of bulimia.
The objective of this project is to assess whether a program of repetitive transcranial magnetic stimulation (rTMS) under high frequency at the left DLPFC reduces bulimic symptoms in the short term.
This is a french multicenter study (Montpellier, Marseille, Saint Etienne), randomized, single blind, two arm, in addition of a treatment already validated (prescription of selective inhibitors of serotonin reuptake inhibitors (SSRIs)). The two arms are : one arm with SSRI + rTMS and an arm with SSRI + sham rTMS (placebo), 30 patients per group will be recruited.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnostic of bulimia nervosa (DSM IV)
- •Women (18-40 years old)
- •right-handed
- •treated by fluoxetine (60mg/j) or escitalopram (30mg/j) for at least 3 weeks.
- •use effective contraceptive measures
排除标准
- •Current anorexia as DSM IV criteria
- •Current psychiatric disorder unstabilized
- •Taking corticosteroid
- •History of seizures or epilepsy
- •History of head trauma, cerebral pathology
- •Serious physical illness unstabilized
- •Prior use of the TMS
- •pregnancy or breastfeeding
- •Somatic disease may affect cognitive abilities and brain structures
- •Loss of personal capacity resulting in state protection
- •Deprivation of liberty by judicial or administrative decision
- •Patients with pacemakers, defibrillator, neuro stimulator implanted.
研究组 & 干预措施
rTMS
patients included in this arm will receive 10 sessions of transcranial magnetic stimulation (10 TMS sessions of 20 trains of 5s with 55s interval cross train, at a frequency of 10 Hz and 110% of motor threshold intensity of the left DLPFC).
Fifty percent of patients will be included in this arm. During the first and last session a food challenge task will be administered before and after rTMS. Salivary cortisol level will be assessed throughout the protocol Intervention: Repetitive transcranial Magnetic Stimulation (rTMS)
干预措施: Repetitive transcranial Magnetic Stimulation (rTMS) (Procedure)
rTMS SHAM
Transcranial magnetic stimulation SHAM Intervention: Repetitive transcranial Magnetic Stimulation SHAM Fifty percent of patients will be included in this arm. During the first and last session a food challenge task will be administered before and after rTMS. Salivary cortisol level will be assessed throughout the protocol
干预措施: Repetitive transcranial Magnetic Stimulation SHAM (Procedure)
结局指标
主要结局
Efficiency of rTMS in bulimia
时间窗: At J0 and J45 (maximum of 45 days between the inclusion visit and the final visit)
The objective of this project is to assess whether a program of repetitive transcranial magnetic stimulation (rTMS) under high frequency at the left DLPFC reduces bulimic symptoms in the short term. To do this we will count the number of binge during the 15 days following the last session of rTMS.
次要结局
未报告次要终点