HyperphagiaNCT01863017
Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome
A study testing tDCS in people with Hyperphagia and Prader-Willi Syndrome, run by University of Kansas Medical Center at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperphagia, Prader-Willi Syndrome
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to 6 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
Prader-Willi Homes of Oconomowoc
Dousman, Wisconsin, 53118
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation- Induced Modulation of Hyperphagia in Prader-Willi Syndrome
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).
Read the 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.
- Conditions
- Hyperphagia, Prader-Willi Syndrome
- Being tested
- tDCS
- Keywords
- Obesity, Over weight
- Medical subject headings
- Hyperphagia, Prader-Willi Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called ActivaDoseII
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Total Score Day 30
Secondary outcomes (1)
Three-Factor Eating Questionnaire
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). Higher scores indicate more severe pathology.
Measured: Total Scores at Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startApr 2013
- Primary completion6 Oct 2016
- Study completion6 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperphagiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Prader-Willi Syndrome Association USA, Harvard Medical School (HMS and HSDM), Foundation for Prader-Willi Research
- Responsible party
- Sponsor
- Investigators
- Merlin G. Butler, MD, PhD, Principal investigator, University of Kansas Medical CenterFelipe Fregni, MD, PhD, MPH, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863017
- Sponsor's protocol ID
- 13155
- Status last verified
- Apr 2019
- First submitted
- 30 Apr 2013
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26590516
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation- Induced Modulation of Hyperphagia in Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT01863017
- Acronym / sponsor ID
- 13155
- Conditions
- Hyperphagia, Prader-Willi Syndrome
- Keywords
- Obesity, Over weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Prader-Willi Syndrome Association USA, Harvard Medical School (HMS and HSDM), Foundation for Prader-Willi Research
- Study start
- Apr 2013
- Primary completion
- 6 Oct 2016 (actual)
- Study completion
- 6 Oct 2016 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS | Sham comparator | Device: tDCSFive 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. |
| Active tDCS | Experimental | Device: tDCSFive 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- Subject is pregnant at time of enrollment in the study.
- Contraindications to tDCS:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: ActivaDoseII | Device | Active tDCS, Sham tDCS |
Primary outcome
Amplitude of Eyeblink Startle Responses
Time frame: Amplitude of Eyeblink Startle at Day 30 relative to normal weight controls
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.
Dykens Hyperphagia Questionnaire
Time frame: Total Score Day 30
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.
1 secondary outcome
Three-Factor Eating Questionnaire
Time frame: Total Scores at Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26590516Bravo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merlin G. Butler, MD, PhD principal investigator
University of Kansas Medical Center
Felipe Fregni, MD, PhD, MPH principal investigator
Spaulding Rehabilitation Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Hyperphagia and Prader-Willi Syndrome, run by University of Kansas Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of Eyeblink Startle Responses (time frame: Amplitude of Eyeblink Startle at Day 30 relative to normal weight controls). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.