NCT04032639|Unknown
Stress and Brain Response Using MEG in PWS
Chronic Stress, Cognition, and Food Cue Reactivity in Prader-Willi Syndrome: A Magnetoencephalography Study
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Chronic Stress, Cognition, and Food Cue Reactivity in Prader-Willi Syndrome: A Magnetoencephalography Study
Sponsor study identifier
observational
48
1 country
2
Study Start
May 30, 2019
Actual (reported)Primary Completion
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2019
Actual (reported)July 11, 2019
Actual (reported)July 25, 2019
Actual (reported)May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Neuronal activity during the food cue reactivity task
To compare neuronal activity between PWS and controls during the food cue task
2 years
Relationships between appetite hormone response and neuronal activity during the food cue task
2 years
Relationships between cortisol and neuronal activity during the food cue reactivity task
2 years
Neuronal activity during the emotional processing task
2 years
Neuronal activity during resting state
2 years
Neuronal activity during the response inhibition task
2 years
Relationships between neuropsychological function and neuronal activity during the food cue reactivity task
2 years
Relationships between neuropsychological function and neuronal activity during the response inhibition task
2 years
24 children and adolescents (7-16 years) with diagnosed Prader-Willi Syndrome will be recruited
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
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
The Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
A fasting blood sample will be collected to measure glucose, insulin, cortisol, active peptide YY, and active ghrelin
Jill Hamilton, MD
The Hospital for Sick Children
First Submitted
July 11, 2019
First Posted
July 25, 2019
Study Start
May 30, 2019
Actual (reported)Primary Completion
May 2023
Estimated (date passed)An Open-Label Study of DCCR Tablet in Patients With PWS
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 13, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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