Stress and Brain Response Using MEG in PWS

NCT04032639 | Unknown

• 1 other identifier: 1000061983
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prader-Willi Syndrome

Keywords

Prader-Willi Syndrome; Magnetoencephalography; Food Cue Reactivity; Stress

Outcome Measures

Primary Outcomes (1)

• Neuronal activity during the food cue reactivity task

  To compare neuronal activity between PWS and controls during the food cue task

  2 years

Secondary Outcomes (7)

• 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

Other Outcomes (2)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Genetically diagnosed PWS (study population)
• Adolescents matched for age, sex, and BMI-percentile (controls)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Holland Bloorview Kids Rehabilitation Hospital: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A fasting blood sample will be collected to measure glucose, insulin, cortisol, active peptide YY, and active ghrelin

MeSH Terms

Conditions

Prader-Willi Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jill Hamilton, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill K Hamilton, MD

CONTACT

416-813-5115; jill.hamilton@sickkids.ca

Barkha Patel, PhD

CONTACT

416-813-7654; barkha.patel@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 25, 2019
• Study Start: May 30, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

CA (2)