Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation- Induced Modulation of Hyperphagia in Prader-Willi Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Amplitude of Eyeblink Startle Responses
研究概览
简要总结
The purpose of this study is to determine the effects of transcranial direct current stimulation (tDCS) as it modifies hyperphagia in obese subjects, non-obese subjects, and subjects with Prader-Willi syndrome (PWS).
详细描述
PWS is characterized by hypotonia, feeding difficulties, developmental delay and failure to thrive during infancy, and by an insatiable appetite (hyperphagia), rapid weight gain and obesity in early childhood.
Hyperphagia is one of the most prominent and debilitating features of PWS, and currently no pharmaceutical drug has been successful in decreasing appetite in such patients.
tDCS is a safe, noninvasive method whereby a weak electric current is directly transmitted into the brain via external electrodes connected to a 9-volt radio battery. It is based on decades-old observations that nerve cell firing can be altered by low amplitude direct current (DC). The researchers in this study believe that tDCS may have a positive impact on hyperphagia and weight.
In this study, the investigators intend to assess whether the effects tDCS differ between obese subjects, non-obese subjects, and subjects with Prader-Willi syndrome by measuring the amplitude and latency of eyeblink startle responses to a set of food- and non-food-related visual stimuli in all subjects, various hyperphagia questionnaires, and cognitive and behavioral assessments. It is hypothesized that as a group, subjects with Prader-Willi syndrome will demonstrate behavioral and psychometric evidence of abnormal food image processing, craving and associated behaviors relative to our control groups, and this group may receive potentially beneficial effects from tDCS sessions. Obese subjects are also predicted to have decreased hyperphagia and food cravings as a result of tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals and individuals diagnosed with Prader-Willi syndrome
- •Provide informed consent to participate in the study
- •Body Mass Index (BMI) <25kg/m2 (for non-obese subjects only)
- •Body Mass Index (BMI) ≥30kg/m2 (for obese subjects only)
排除标准
- •Subject is pregnant at time of enrollment in the study.
- •Contraindications to tDCS:
- •metal in the head
- •implanted brain medical devices
- •Clinically significant and unstable medical disorders (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease) as self-reported.
- •Clinically significant and unstable psychiatric disorders (e.g., schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, severe depression) as self-reported.
- •Significant visual impairment, as self-reported
- •History of auditory deficiencies, as self-reported
- •History of alcohol or substance abuse within the last 6 months as self-reported
- •Use of carbamazepine within the past 6 months as self-reported.
- •Current use of antidepressants
- •History of neurological disorders as self-reported
- •History of neurosurgery as self-reported
研究组 & 干预措施
Sham tDCS
Five consecutive sessions of no tDCS. Each session will last approximately 30 minutes. Current will be applied for 20 minutes. Less than 3 minutes of tDCS has been shown to induce no lasting effects. Normal weight control participants will receive one sham session and one active session.
干预措施: tDCS (Device)
Active tDCS
Five consecutive sessions of tDCS administered. Each session will take about 30 minutes. Normal weight control participants will receive one sham session and one active session.
干预措施: tDCS (Device)
结局指标
主要结局
Amplitude of Eyeblink Startle Responses
时间窗: Amplitude of Eyeblink Startle at Day 30 relative to normal weight controls
Muscle contractions generated by the orbicularis oculi were recorded by a BIOPAC systems bioamplifier (model EMG 100c) passing 10-500 Hz signals, sampling at a rate of 2000/second and amplified by a factor of 5000. Eyeblink startle-responses were measured in response to food and non-food images at two lead-intervals (2500 ms and 6000 ms) to assess emotional responses (e.g., early and late, respectively) for each picture stimulus. Startle responses were assessed during (e.g., while viewing the food, puppy, etc.) and between (e.g., during washout periods; no-images) visual image-processing. Omnibus amplitudes are presented for sham vs active treatment groups for all participants, individuals with obesity and Prader Willi syndrome relative to lean controls.
Dykens Hyperphagia Questionnaire
时间窗: Total Score Day 30
The Dykens Hyperphagia Questionnaire is a 13-item instrument that was specifically designed to measure food-related preoccupations and problems, as well as the severity of these concerns. Items on the questionnaire are rated on a five-point scale (1: not a problem to 5: severe and/or frequent problem). Possible scores on the questionnaire range from a minimum score of 0 to a maximum score of 65. Higher scores indicate greater hyperphagia.
次要结局
- Three-Factor Eating Questionnaire(Total Scores at Day 30)