Stress and Brain Response Using MEG in PWS

NCT ID: NCT04032639

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-30

Study Completion Date

2024-05-31

Brief Summary

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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

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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

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Prader-Willi Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Prader-Willi Syndrome

24 children and adolescents (7-16 years) with diagnosed Prader-Willi Syndrome will be recruited

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Jill Hamilton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill Hamilton, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jill K Hamilton, MD

Role: CONTACT

416-813-5115 ext. 205115

Barkha Patel, PhD

Role: CONTACT

416-813-7654 ext. 201915

Facility Contacts

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Barkha Patel, PhD

Role: primary

416-813-7654 ext. 201915

Jill Hamilton, MD

Role: primary

(416) 913-5115

Other Identifiers

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1000061983

Identifier Type: -

Identifier Source: org_study_id

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