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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Prader-Willi Syndrome Association USA
Harvard Medical School
Information provided by (Responsible Party):
Merlin G. Butler, MD, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01863017
First received: April 30, 2013
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Hyperphagia
Prader-Willi Syndrome
Device: tDCS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation- Induced Modulation of Hyperphagia in Prader-Willi Syndrome

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Amplitude of eyeblink startle responses [ Time Frame: Change from Baseline to Week 6 ] [ Designated as safety issue: No ]

    Comparing the amplitude of eyeblink startle responses to a set of food- and non-food-related visual stimuli in all subjects to measure effect of tDCS.

    Muscle contractions generated by the orbicularis oculi will be 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 will be measured 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 will be assessed during (e.g., while viewing the food, puppy, etc.) and between (e.g., during washout periods; no-images) visual image-processing.



Secondary Outcome Measures:
  • Latency of eyeblink startle responses [ Time Frame: Change from Baseline to Week 6 ] [ Designated as safety issue: No ]

    Comparing the latency of eyeblink startle responses to a set of food- and non-food-related visual stimuli in all subjects to measure effect of tDCS.

    Muscle contractions generated by the orbicularis oculi will be 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 will be measured 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 will be assessed during (e.g., while viewing the food, puppy, etc.) and between (e.g., during washout periods; no-images) visual image-processing.



Other Outcome Measures:
  • Dykens Hyperphagia Questionnaire [ Time Frame: Change from Baseline to Week 6 ] [ Designated as safety issue: No ]

    Use of Dykens Hyperphagia Questionnaire to assess whether active anodal tDCS stimulation of the right frontal brain cortex modifies hyperphagia in subjects with Prader-Willi syndrome when compared with sham or no stimulation in relationship to similar healthy obese controls.

    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).


  • Three-Factor Eating Questionnaire [ Time Frame: Change from Baseline to Week 6 ] [ Designated as safety issue: No ]

    Use of Three-Factor Eating Questionnaire to assess whether active anodal tDCS stimulation of the right frontal brain cortex modifies hyperphagia in subjects with Prader-Willi syndrome when compared with sham or no stimulation in relationship to similar healthy obese controls.

    The Three-Factor Eating Questionnaire is a self-completed, 51-item questionnaire that measures both cognitive and behavioral aspects of eating (dietary restraint, disinhibition, and hunger), and comprises two parts. Part 1 includes 36 true/false questions, and part 2 includes 14 questions on a four point Likert scale (1= rarely, 2 = sometimes, 3 = usually, 4 = always) and 1 question on a five point Likert scale (1 = eat whatever you want, whenever you want it to 5 = constantly limiting food intake, never 'giving in'; other questions).



Estimated Enrollment: 36
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 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.
Device: tDCS
Other Name: ActivaDoseII
Experimental: 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.
Device: tDCS
Other Name: ActivaDoseII

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

    1. metal in the head
    2. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863017

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Merlin G. Butler, MD, PhD
Prader-Willi Syndrome Association USA
Harvard Medical School
Investigators
Principal Investigator: Merlin G. Butler, MD, PhD University of Kansas
Principal Investigator: Felipe Fregni, MD, PhD, MPH Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Merlin G. Butler, MD, PhD, Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01863017     History of Changes
Other Study ID Numbers: 13155
Study First Received: April 30, 2013
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Obesity
Over weight

Additional relevant MeSH terms:
Hyperphagia
Prader-Willi Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 11, 2014