Prader-Willi SyndromeNCT04032639
Stress and Brain Response Using MEG in PWS
An observational study of Prader-Willi Syndrome, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
Individuals with Prader-Willi Syndrome (PWS) have increased hunger and food seeking behaviour, as well as learning (cognitive) challenges. In addition, some patients with PW been shown to have low cortisol production, particularly in stressful situations. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Prader-Willi Syndrome
- How many people
- 48 participants
- Where
- 2 sitesCanada
- Study dates
- 30 May 2019to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Prader-Willi Syndrome (PWS) is characterized by hyperphagia, although the degree of food seeking can vary between individuals. The characteristic endocrine and metabolic dysfunction in PWS is indicative of abnormalities in the hypothalamus, and other brain systems. In addition to the hyperphagia and risk for obesity, anxiety is a prominent feature of PWS
Who may be able to join
- Genetically diagnosed PWS (study population)
- Adolescents matched for age, sex, and BMI-percentile (controls)
Who cannot join
- Past or current history of alcoholism or consistent drug use
- Current untreated major psychiatric illness as defined by the DSM-V criteria
- Medications that decrease alertness (that cannot be held on the days of testing)
- History of recent major head trauma
- Current pregnancy
- Diagnosis of diabetes
Show all 9Show fewer
- Current or recent smoker (i.e. >2 cigarettes/week during past year)
- History of metal in body (shrapnel, metal slivers, unremovable metal adornments, clips, top braces, pacemaker)
- Use of glucocorticoid medications
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
Barkha Patel, PhD, 416-813-7654 ext. 201915, barkha.patel@sickkids.ca
Jill Hamilton, MD
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
Jill Hamilton, MD, (416) 913-5115, jill.hamilton@sickkids.ca
Jill Hamilton, MD
About this study
Official title: Chronic Stress, Cognition, and Food Cue Reactivity in Prader-Willi Syndrome: A Magnetoencephalography Study
Individuals with Prader-Willi Syndrome (PWS) have increased hunger and food seeking behaviour, as well as learning (cognitive) challenges. In addition, some patients with PW been shown to have low cortisol production, particularly in stressful situations. However, research examining how hormonal, cognitive, and psychological factors are interrelated PWS is limited. To address this gap in knowledge, the goal of this project is to understand how changes in brain regions involved in controlling food intake and cognitive processes are related to changes in hormones regulating appetite, the stress hormone cortisol, and performance on neuropsychological tests.
Read the detailed description
Prader-Willi Syndrome (PWS) is characterized by hyperphagia, although the degree of food seeking can vary between individuals. This behaviour may be moderated by hormonal, neurocognitive, and psychological factors; however, data assessing these factors in an integrated fashion is scarce. The proposed research will address and identify relationships between three major challenges in PWS: 1) dysregulated feeding behaviour, 2) cognitive performance, and 3) chronic stress. The investigators will measure brain response to food cues, during a cognitive task, and at rest using magnetoencephalography (MEG) in adolescents with PWS and BMI-matched controls. This is an innovative design as previous studies in this population used only functional magnetic resonance imaging (fMRI) to examine food cue reactivity, which does not directly measure neuronal activity and lacks temporal-sensitivity. In contrast, MEG directly records neural firing and combines high spatial resolution with exquisite temporal resolution, allowing us to measure functional connectivity between brain regions. Importantly, MEG is also patient-friendly with fewer contraindications than MRI. To assess cognitive function, the investigators will utilize gold-standard neuropsychological measures, as well as emotional and social behavioural functioning. Lastly, the investigators will assess hair cortisol, which is a reflection of long term, month-by-month cortical exposure. This new area of research will explore neurobiological and cognitive mechanisms controlling feeding behaviour in PWS.
- Conditions
- Prader-Willi Syndrome
- Keywords
- Prader-Willi Syndrome, Magnetoencephalography, Food Cue Reactivity, Stress
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prader-Willi Syndrome | 24 children and adolescents (7-16 years) with diagnosed Prader-Willi Syndrome will be recruited | |
| Controls | 24 children and adolescents (7-16 years) without diagnosed Prader-Willi Syndrome will be matched for age, sex, and BMI-percentile to the Prader-Willi group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuronal activity during the food cue reactivity task
To compare neuronal activity between PWS and controls during the food cue task
Measured: 2 years
Secondary outcomes (7)
Relationships between appetite hormone response and neuronal activity during the food cue task
To compare how appetite hormones correlate with neuronal activity in PWS compared to controls
Measured: 2 years
Relationships between cortisol and neuronal activity during the food cue reactivity task
To compare how stress correlates with neuronal activity in PWS compared to controls
Measured: 2 years
Neuronal activity during the emotional processing task
To compare neuronal activity between PWS and controls during the emotional processing task
Measured: 2 years
Neuronal activity during resting state
To compare neuronal activity between PWS and controls during resting state
Measured: 2 years
Neuronal activity during the response inhibition task
To compare neuronal activity between PWS and controls during the response inhibition task
Measured: 2 years
Relationships between neuropsychological function and neuronal activity during the emotional processing task
To compare how neuropsychological function correlate with neuronal activity in PWS compared to controls
Measured: 2 years
Relationships between cortisol and neuronal activity during the emotional processing task
To compare how stress correlates with neuronal activity in PWS compared to controls
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start30 May 2019
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Holland Bloorview Kids Rehabilitation Hospital, University of Western Ontario, Canada
- Responsible party
- Principal investigator, Jill Hamilton, The Hospital for Sick Children
- Investigators
- Jill Hamilton, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032639
- Sponsor's protocol ID
- 1000061983
- Status last verified
- Sep 2022
- First submitted
- 11 Jul 2019
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Stress, Cognition, and Food Cue Reactivity in Prader-Willi Syndrome: A Magnetoencephalography Study
- ClinicalTrials.gov ID
- NCT04032639
- Acronym / sponsor ID
- 1000061983
- Conditions
- Prader-Willi Syndrome
- Keywords
- Prader-Willi Syndrome, Magnetoencephalography, Food Cue Reactivity, Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Holland Bloorview Kids Rehabilitation Hospital, University of Western Ontario, Canada
- Study start
- 30 May 2019 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with Prader-Willi Syndrome (PWS) have increased hunger and food seeking behaviour, as well as learning (cognitive) challenges. In addition, some patients with PW been shown to have low cortisol production, particularly in stressful situations. However, research examining how hormonal, cognitive, and psychological factors are interrelated PWS is limited. To address this gap in knowledge, the goal of this project is to understand how changes in brain regions involved in controlling food intake and cognitive processes are related to changes in hormones regulating appetite, the stress hormone cortisol, and performance on neuropsychological tests.
Detailed description
Prader-Willi Syndrome (PWS) is characterized by hyperphagia, although the degree of food seeking can vary between individuals. This behaviour may be moderated by hormonal, neurocognitive, and psychological factors; however, data assessing these factors in an integrated fashion is scarce. The proposed research will address and identify relationships between three major challenges in PWS: 1) dysregulated feeding behaviour, 2) cognitive performance, and 3) chronic stress. The investigators will measure brain response to food cues, during a cognitive task, and at rest using magnetoencephalography (MEG) in adolescents with PWS and BMI-matched controls. This is an innovative design as previous studies in this population used only functional magnetic resonance imaging (fMRI) to examine food cue reactivity, which does not directly measure neuronal activity and lacks temporal-sensitivity. In contrast, MEG directly records neural firing and combines high spatial resolution with exquisite temporal resolution, allowing us to measure functional connectivity between brain regions. Importantly, MEG is also patient-friendly with fewer contraindications than MRI. To assess cognitive function, the investigators will utilize gold-standard neuropsychological measures, as well as emotional and social behavioural functioning. Lastly, the investigators will assess hair cortisol, which is a reflection of long term, month-by-month cortical exposure. This new area of research will explore neurobiological and cognitive mechanisms controlling feeding behaviour in PWS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prader-Willi Syndrome | – | –24 children and adolescents (7-16 years) with diagnosed Prader-Willi Syndrome will be recruited |
| Controls | – | –24 children and adolescents (7-16 years) without diagnosed Prader-Willi Syndrome will be matched for age, sex, and BMI-percentile to the Prader-Willi group |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Prader-Willi Syndrome (PWS) is characterized by hyperphagia, although the degree of food seeking can vary between individuals. The characteristic endocrine and metabolic dysfunction in PWS is indicative of abnormalities in the hypothalamus, and other brain systems. In addition to the hyperphagia and risk for obesity, anxiety is a prominent feature of PWS
Key inclusion criteria (2 listed)
- Genetically diagnosed PWS (study population)
- Adolescents matched for age, sex, and BMI-percentile (controls)
Key exclusion criteria (9 listed)
- Past or current history of alcoholism or consistent drug use
- Current untreated major psychiatric illness as defined by the DSM-V criteria
- Medications that decrease alertness (that cannot be held on the days of testing)
- History of recent major head trauma
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuronal activity during the food cue reactivity task
Time frame: 2 years
To compare neuronal activity between PWS and controls during the food cue task
7 secondary outcomes
Relationships between appetite hormone response and neuronal activity during the food cue task
Time frame: 2 years
Relationships between cortisol and neuronal activity during the food cue reactivity task
Time frame: 2 years
Neuronal activity during the emotional processing task
Time frame: 2 years
Neuronal activity during resting state
Time frame: 2 years
Neuronal activity during the response inhibition task
Time frame: 2 years
Relationships between neuropsychological function and neuronal activity during the emotional processing task
Time frame: 2 years
Relationships between cortisol and neuronal activity during the emotional processing task
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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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.
Jill Hamilton, MD principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prader-Willi Syndrome, run by The Hospital for Sick Children at 2 sites in Canada.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill K Hamilton, MD (416-813-5115 ext. 205115, jill.hamilton@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuronal activity during the food cue reactivity task (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2022; AzTrials last refreshed its copy on 29 Oct 2026.