Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Biochemical Markers of Inflammation and Oxidative Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- change in the executive brain functions - cognitive flexibility
研究概览
简要总结
From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information. Provoking changes in neuroplasticity and cortical excitability contribute to the regulation of neural activity. Both could be modified by applying direct electrical current to the sensorimotor cortex, with polarity/current-dependent results, and their effect would last for hours after the end of stimulation. Transcranial Direct Current Stimulation (tDCS), translated into Portuguese as Estimulação Transcraniana por Corrente Contínua (ETCC) is a neuromodulating tool in which a low-intensity electrical current is applied to the scalp to modulate neuronal activity.
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)
盲法说明
Participants do not know what treatment they will receive. The outcomes assessor does not know treatment aplicado in participants sham or real).
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being a health professional at the HU-UFPI (higher and technical levels);
- •both sexes;
- •Age between 20 and 59 years old.
排除标准
- •Participants with communication disabilities (outbound or inbound);
- •Type 1 and 2 diabetes
- •low Body Mass Index (BMI; below 18.5),
- •intracranial metal clip and/or prostheses;
- •Abrupt change in weight (> 5 kg) in the last six months;
- •the use will be excluded recreational use of psychoactive drugs,
- •Being a smoker or using nicotine (tablet / absorbent),
- •Having had significant recent trauma or traumatic brain injury,
- •Present history of epilepsy,
- •to be pregnant or under suspicion
- •Missing teeth;
- •Medical diagnosis of eating disorder or any psychiatric disorder,
- •Having or having had cancer,
- •Diagnosis of heart disease.
研究组 & 干预措施
tDCS + speech therapy+ sham
Participants will receive real tDCS and tDCS sham for 5 sessions during each treatment period. The interstice period of the total intervention will be 25 days, with 15 days of wash out between the two interventions. The probabilistic, simple randomized sample will consist of participants with food cravings randomized into two groups, according to the presence or absence of changes in eating behavior and within each group there will be subdivision to receive or not neuromodulation, according to the flowchart
干预措施: speech therapy for chewing + real tDCS (Behavioral)
sham + tDCS + speech therapy
Participants will receive real tDCS and tDCS sham for 5 sessions during each treatment period. The interstice period of the total intervention will be 25 days, with 15 days of wash out between the two interventions. The probabilistic, simple randomized sample will consist of participants with food cravings randomized into two groups, according to the presence or absence of changes in eating behavior and within each group there will be subdivision to receive or not neuromodulation, according to the flowchart
干预措施: speech therapy for chewing + real tDCS (Behavioral)
结局指标
主要结局
change in the executive brain functions - cognitive flexibility
时间窗: post-intervention (immediately after the end of study participation).
Stroop Tests. Assessments with single measurements (measurement of time, in seconds, to perform the test). the measurement unit for evaluating the outcome of these tests will be the amount of errors presented and the execution time (in seconds). The shorter the time and fewer errors, the better the result.
change in desire to consume food.
时间窗: post-intervention (immediately after the end of study participation).
Questionnaires of Intense Food Desires - Trait (QDIC-T) validated for Brazilian Portuguese. The higher the score, the greater the amount of food craving presented. The QDIC-T scale is done on a 6-point scale with scores ranging from 39 to 214 points.
change in the executive brain functions - working memory
时间窗: pre-intervention.
Trial Making Test (A and B). Assessments with single measurements (measurement of time, in seconds, to perform the test). the measurement unit for evaluating the outcome of these tests will be the amount of errors presented and the execution time (in seconds). The shorter the time and fewer errors, the better the result.
change in desire to consume food.
时间窗: pre-intervention.
Questionnaires of Intense Food Desires - Trait (QDIC-T) validated for Brazilian Portuguese. The higher the score, the greater the amount of food craving presented.The QDIC-T scale is done on a 6-point scale with scores ranging from 39 to 214 points.
次要结局
- change in the final value of inflammation scores(post-intervention (immediately after the end of study participation).)
- change in the final value of antioxidant activity(post-intervention (immediately after the end of study participation).)
- change in desire to consume food.(post-intervention (immediately after the end of study participation).)
- change in the final value of inflammation scores(pre-intervention.)
- change in the final value of antioxidant activity(pre-intervention.)
- change in desire to consume food.(pre-intervention.)
研究者
Marta Maria da Silva Lira Batista
Principal Investigator
Federal University of Piaui