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

NCT01863017 | Completed Results

• 1 other identifier: 13155
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

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 syndrome (PWS).

Conditions

Hyperphagia; Prader-Willi Syndrome

Keywords

Obesity; Over weight

Outcome Measures

Primary Outcomes (2)

• Amplitude of Eyeblink Startle Responses

  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.

  Amplitude of Eyeblink Startle at Day 30 relative to normal weight controls

• Dykens Hyperphagia Questionnaire

  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.

  Total Score Day 30

Secondary Outcomes (1)

• Three-Factor Eating Questionnaire

  Total Scores at Day 30

Study Arms (2)

Sham tDCS

SHAM COMPARATOR

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.

Device: tDCS

Active tDCS

EXPERIMENTAL

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.

Device: tDCS

Interventions

tDCS DEVICE

Also known as: ActivaDoseII

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Prader-Willi Syndrome Association USA: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Foundation for Prader-Willi Research: collaborator

Study Sites (3)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

Prader-Willi Homes of Oconomowoc

Dousman, Wisconsin, 53118, United States

Location

Related Publications (1)

• Bravo GL, Poje AB, Perissinotti I, Marcondes BF, Villamar MF, Manzardo AM, Luque L, LePage JF, Stafford D, Fregni F, Butler MG. Transcranial direct current stimulation reduces food-craving and measures of hyperphagia behavior in participants with Prader-Willi syndrome. Am J Med Genet B Neuropsychiatr Genet. 2016 Mar;171B(2):266-75. doi: 10.1002/ajmg.b.32401. Epub 2015 Nov 21.

  PMID: 26590516 BACKGROUND

MeSH Terms

Conditions

Hyperphagia; Prader-Willi Syndrome; Obesity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Merlin G Butler
• Organization: University of Kansas Medical Center

mbutler4@kumc.edu

9135881800

Study Officials

• Merlin G. Butler, MD, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 27, 2013
• Study Start: April 1, 2013
• Primary Completion: October 6, 2016
• Study Completion: October 6, 2016
• Last Updated: April 26, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Locations

US (3)