N/A
N=31
Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome
Hyperphagia · Prader-Willi Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01863017 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Amplitude of Eyeblink Startle Responses — 0.006; 0.001; 0.008; 0.001 microvolts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tDCS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amplitude of Eyeblink Startle Responses |
0.006; 0.001; 0.008; 0.001; 0.004; 0.001 | — |
| PRIMARY Dykens Hyperphagia Questionnaire |
19.8; 22.1; 15.3; 24.8; 28.3; 25.3 | — |
| SECONDARY Three-Factor Eating Questionnaire |
19.82; 20.5; 16.3; 25.1; 32.7; 27.8 | — |
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 syndrome (PWS).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01863017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.