Effect of Nutritional Counseling Associated With Transcranial Direct-current Stimulation in Binge Eating Reduction: A Single-blinded, Randomized Clinical Trial in Parallel With Simulated Use
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Binge Eating Scale (BES)
研究概览
简要总结
Binge eating disorder is the most prevalent eating disorder, with consequences not only economic but also social. It is related to a set of cognitive alterations related to impulsivity, cognitive function, attention, decision making, emotional control and physiological alterations in the Central nervous system (CNS) in the processing of rewards, mainly in the frontal cortical regions. Psychotherapies are the standard reference treatments, with Cognitive Behavioral Therapy (CBT) being the most indicated nonpharmacological intervention. However, the avoidance rates and the rates of non responders to treatment are significant. In view of this, it is believed that therapeutic approaches aimed at the modulation of the CNS, such as Transcranial direct-current stimulation (tDCS) may have a beneficial effect on the neurobiology of the processes that govern these disorders, thus adding to the effects of CBT and amplifying the therapeutic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only the tDCS intervention was masked
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •right - handed individuals
- •body mass index ≥ 25 kg / m2
- •meet the criteria of the Statistical Diagnostic Manual of Mental Disorders 5th edition (DSM - V) for Binge eating (4 to 7 episodes of binge eating per week).
排除标准
- •Pregnancy
- •shift workers
- •treatment for weight loss in the last 30 days
- •bariatric surgery
- •formal contraindication for tDCS
结局指标
主要结局
Binge Eating Scale (BES)
时间窗: 20 minutes
The Binge Eating Scale is a sixteen item questionnaire used to assess the presence of binge eating behavior indicative of an eating disorder. The questions are based upon both behavioral characteristics (e.g., amount of food consumed) and the emotional, cognitive response, guilt or shame. Each question has 3-4 separate responses assigned a numerical value. The score range is from 0-46= Non-binging (less than 17); Moderate binging (18-26); Severe binging (27 and greater).
Short latency intracortical inhibition
时间窗: 40 minutes
Cortical excitability reflects a balance between inhibitory and facilitatory neuronal circuits projected through pyramidal tract output tracts. Transcranial magnetic simulation (TMS) applied to the primary motor cortex (M1) has become widely utilized to assess cortical physiology using paired-pulse paradigms. Preceding subthreshold conditioning stimulus (CS) inhibits the excitability of the motor cortex, which is named short-interval intracortical inhibition (SICI). SICI is a standard method to estimate excitability in a GABAA-ergic circuit in the human cortex;
次要结局
- % Reduction of waist circumference(5 minutes)
- % Weight loss change(5 minutes)
- State and Trait Food Craving Questionnaire (FCQ)(40 minutes)
- Intracortical Facilitation(40 minutes)
- Leptin(5 minutes)
- Go/No-go(20 minutes)
- Three Factor Eating-Questionnaire (TFEQ-R21)(15 minutes)
- Silent period(40 minutes)
研究者
Wolnei Caumo
Professor, surgery departament
Hospital de Clinicas de Porto Alegre