Status:
COMPLETED
Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
Prader-Willi Syndrome Association USA
Harvard Medical School (HMS and HSDM)
Conditions:
Hyperphagia
Prader-Willi Syndrome
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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...
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01863017
Start Date
April 1 2013
End Date
October 6 2016
Last Update
April 26 2019
Active Locations (3)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
3
Prader-Willi Homes of Oconomowoc
Dousman, Wisconsin, United States, 53118