Stress and Brain Response Using MEG in PWS

Prader-Willi Syndrome Clinical Trial

Official title:

Chronic Stress, Cognition, and Food Cue Reactivity in Prader-Willi Syndrome: A Magnetoencephalography Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04032639
• Other study ID #: 1000061983
• Status: Recruiting
• Start date: May 30, 2019
• Est. completion date: May 2024

Study information

• Verified date: September 2022
• Source: The Hospital for Sick Children
• Contact: Jill K Hamilton, MD
• Phone: 416-813-5115
• Email: jill.hamilton[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

• Genetically diagnosed PWS (study population)

• Adolescents matched for age, sex, and BMI-percentile (controls)

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Holland Bloorview Kids Rehabilitation Hospital, University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationships between neuropsychological function and neuronal activity during the food cue reactivity task	To compare how neuropsychological function correlate with neuronal activity in PWS compared to controls	2 years
Other	Relationships between neuropsychological function and neuronal activity during the response inhibition task	To compare how neuropsychological function correlate with neuronal activity in PWS compared to controls	2 years
Primary	Neuronal activity during the food cue reactivity task	To compare neuronal activity between PWS and controls during the food cue task	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	Neuronal activity during the emotional processing task	To compare neuronal activity between PWS and controls during the emotional processing task	2 years
Secondary	Neuronal activity during resting state	To compare neuronal activity between PWS and controls during resting state	2 years
Secondary	Neuronal activity during the response inhibition task	To compare neuronal activity between PWS and controls during the response inhibition task	2 years
Secondary	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	2 years
Secondary	Relationships between cortisol and neuronal activity during the emotional processing task	To compare how stress correlates with neuronal activity in PWS compared to controls	2 years