The Effect of Brain Neuromodulation on Food Cravings, Cognitive Control and Food Addiction Scales in Overweight/Obese Women Using tDCS
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Yale Food Addiction Scale scores
研究概览
简要总结
This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS). All eligible participants will engage in a behavioral intervention known to enhance control over food cravings and will be randomly assigned to receive either tDCS or sham stimulation to the prefrontal cortex of the brain.
详细描述
This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS) which is a form of stimulation that delivers a low amplitude electrical current to the brain via the scalp (i.e. trans-cranial) to modify brain activity.
All eligible participants will engage in a behavioral intervention (Go-No Go task), known to enhance control over food cravings, and will be randomly assigned to receive either tDCS or sham stimulation to the right prefrontal cortex of the brain during 8 20-min daily sessions.
Primary outcome: score changes in eating behaviors scales (YFAS and TFEQ), scales will be applied at baseline and at the end of the 8 brain stimulation sessions.
Secondary outcomes: changes in diet, brain function (brain MRI/MRS) Other outcomes: food cravings scales and impulse control scales and cognitive function.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed
排除标准
- •History of anorexia nervosa or bulimia or binge eating disorder
- •Any contraindication to undergo MRI
- •Use of psychotropic medications and/or opiate pain medications.
- •Current or past alcohol or drug abuse problem or smoking
- •Pregnancy
- •Current use of weight loss medication or currently participating in a weight loss program.
- •History of seizures, epilepsy or factors/medications associated with lowered seizure threshold.
- •History of brain disease or major neurological disorder or mental disorder
- •History of brain surgery or history of loss of consciousness >15 min
- •History of major gastrointestinal surgery including weight loss surgery
- •History of endocrine imbalances including diabetes, thyroid disease, Cushing's disease, metabolic syndrome and polycystic ovary.
研究组 & 干预措施
tDCS and Go-No Go task
Certain randomly assigned participants will receive tDCS to the DLPFC for 8 daily 20-minute sessions, with a TDCS amplitude of 2 mAmps.
During the tDCS session, individuals will perform a 10-min computerized Go-No Go task
干预措施: tDCS (Device)
tDCS and Go-No Go task
Certain randomly assigned participants will receive tDCS to the DLPFC for 8 daily 20-minute sessions, with a TDCS amplitude of 2 mAmps.
During the tDCS session, individuals will perform a 10-min computerized Go-No Go task
干预措施: Go-No GO task (Behavioral)
Sham brain stimulation and Go-No Go task
Certain randomly assigned participants will receive Sham Stimulation to the DLPFC for 8 daily 20-min sessions. The Sham stimulation is an inactive form of stimulation.
During the sham brain stimulation session, individuals will perform a 10-min computerized Go-No Go task
干预措施: Sham brain stimulation (Device)
Sham brain stimulation and Go-No Go task
Certain randomly assigned participants will receive Sham Stimulation to the DLPFC for 8 daily 20-min sessions. The Sham stimulation is an inactive form of stimulation.
During the sham brain stimulation session, individuals will perform a 10-min computerized Go-No Go task
干预措施: Go-No GO task (Behavioral)
结局指标
主要结局
Change in Yale Food Addiction Scale scores
时间窗: Scores measured at baseline and at up-to 2 weeks after the intervention
Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).
Change in Three-Factor Eating Questionnaire scores
时间窗: Scores measured at baseline and at up-to 2 weeks after the intervention
Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).
次要结局
- Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)(Brain MRS at baseline and up-to 2 weeks after the intervention)
- Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)(Brain function at baseline and up-to 2 weeks after the intervention)
研究者
Claudia P. Sanmiguel, MD
Health Sciences Assistant Professor
University of California, Los Angeles