Pilot Study of an Intervention Involving Cognitive Training and Transcranial Direct-current Stimulation (tDCS) in Morbidly Obese Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Change in food intake
研究概览
简要总结
The study aims to: 1) investigate the effects of cognitive training (CT) and combined CT and transcranial direct current stimulation (tDCS) on food intake and 2) to further understand its neuropsychological and neurophysiological basis (i.e. EEG) as well as its impact in endocannabinoids (EC) in a sample of morbidly obese patients seeking for a gastric bypass surgery
详细描述
The study will explore the impact of a 4-day intervention with either CT (Active control condition) or CT+tDCS (Active condition) stimulation on food intake in a sample of morbidly obese patients, as measured by dietary assessments the week before, during and the week after the intervention. Additionally, to further understand the neuropsychological and neurophysiological basis of its impact, measures of executive function and attention performance and EEG recordings, respectively, will be collected. Furthermore, we will explore the effect of the intervention on endocannabinoids previously related to eating behaviour.
The Active Control condition will receive sham stimulation together with CT, through a computerized cognitive training platform (Guttmann NeuropersonalTrainer), including different tasks with designed to train executive functions and attention. Each session will last approximately 30-40 min.
The Active condition will receive tDCS stimulation (20 min, multichannel with an excitatory target over the r-dlPFC) together with CT (same as for the Active Control condition).
Participants will undergo a basal (the week before intervention) and a post treatment assessments (the day after finishing the intervention) that will include medical history, blood testing, anthropometric measures, a cognitive assessment battery and a 4-day dietary assessment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The difference between the two groups is the tDCS therapy. To mask this difference, the duration time of the session will be the same under both conditions but a standard Sham tDCS protocol will be used for the Active Control group. That is, a 3-sec ramp-up and ramp-down current stimulation, so the subject perceives the current just like the real tDCS, but it is not strong nor durable enough to have any effect on the neuronal activity.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both gender, aged between 18 and 60 years-old
- •Having a BMI > 40 kg/m2 or having a BMI>35 and suffering from diabetes mellitus, HBP or LDP.
- •Obesity conventional treatment failure
- •Wish of bariatric surgery
- •Accepting the study and signing the Informed Consent
排除标准
- •Do not meet inclusion criteria
- •Being left-handed
- •Using a pacemaker or deep cerebral stimulation device
- •Having a psychiatric disease or serious disease
- •Neurologic condition or learning issue or mental backwardness that could affect cognitive function
- •Use of psycho-stimulating medicines and/or drugs, abuse or dependance to a psychoactive substance (or during the last 6 months)
- •Dependance to alcohol or/and drugs (excepted from nicotina)
- •In treatment with benzodiazepines, antipsychotics, tricyclic antidepressants or topiramate, started in the last month
- •History of psychiatric disorders treated with lithio carbonate.
- •Cutaneous lesion on the area of using of electrodes
- •Contact allergy to material used in the used devices.
结局指标
主要结局
Change in food intake
时间窗: 4 consecutive days during the week before starting the treatment; 4 consecutive days during the week of treatment;
Changes in food consumption (medium kcal intake ) from baseline to the end of the treatment measured by 4-day food registers during the week before starting the treatment and during the 4 days of treatment. The dietary records were checked by a nutritionist and analyzed through the software PCN Pro 1.0.
Stability of changes in food intake
时间窗: 4 consecutive days during the week before starting the treatment and 4 consecutive days during the week after finishing the treatment
Changes in food consumption (medium kcal intake ) from baseline to the follow-up assessment measured by 4-day food registers during the week before starting the treatment and the week after finishing the treatment. The dietary records were checked by a nutritionist and analyzed through the software PCN Pro 1.0.
次要结局
- Change in neuropsychological test: Iowa Gambling Task (IGT, Bechara et al., 1994, 2002)(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in neuropsychological test: Spatial Span (SSP; CANTAB Cambridge Cognition)(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in hormonal measurements : Leptin and adiponectin plasmatic/serum concentrations(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in neuropsychological test: Stroop Colours and Words test (SCWT, Golden C.J., 1978; Stroop, 1935)(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in Body Mass Index (BMI)(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in electroencephalogram (EEG) power and coherence(Every training session (4 consecutive days), 3 minutes before starting the training session and 3 minutes after finishing the training.)
- Change in endocannabinoids (and related compounds) plasmatic concentrations.(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in neuropsychological test: Intra-extra dimension (IED-CANTAB Cambridge Cognition)(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in neuropsychological test: Stockings of Cambridge (SOC; CANTAB Cambridge Cognition)(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in neuropsychological test: Conners Continuous Performance Test (CPT, Conners & MHS Staff, 2000)(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in neuropsychological test: Simple Reaction Time (SRT; CANTAB Cambridge Cognition)(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
- Change in neuropsychological test:Symbol digit modalities test (SDMT; Smith A. 1982).(One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment))
研究者
Albert Goday Arno
Medical doctor
Parc de Salut Mar