Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Hyperphagia, Prader-Willi Syndrome

In brief

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).

Key facts

Study ID

NCT01863017

Run by

University of Kansas Medical Center

People needed

31

Starts

2013-04-01

Expected to finish

2016-10-06

Last updated by the study team

2019-04-26

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States
• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
• Prader-Willi Homes of Oconomowoc — Dousman, Wisconsin, United States

Full record on ClinicalTrials.gov

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