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Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)

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ClinicalTrials.gov Identifier: NCT01838018
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : May 28, 2018
Sponsor:
Collaborators:
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
Susan J. Hayflick, Oregon Health and Science University

Brief Summary:
The purpose of this study is to learn whether blood flow in the brain is normal in people with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN, may have reduced blood flow. Standard MRI and perfusion scanning techniques will be used to learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other brain regions as well as to healthy controls.

Condition or disease
Pantothenate Kinase-associated Neurodegeneration (PKAN)

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Brain Perfusion in Pantothenate Kinase-Associated Neurodegeneration (PKAN)
Actual Study Start Date : April 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : January 2018


Group/Cohort
PKAN
This group consists of individuals diagnosed with PKAN using a combination of MRI and PANK2 gene sequencing.
Healthy volunteers
This is a control group of healthy volunteers, matched with the PKAN group for age and sex.



Primary Outcome Measures :
  1. ASL-derived cerebral blood flow(CBF) [ Time Frame: Single MRI ]
    The unit of analyses will be the subject and the primary comparison will be the globus pallidus CBF between PKAN and healthy controls.



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Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The PKAN group consists of individuals in the United States diagnosed with PKAN.
Criteria

Inclusion Criteria:

  • diagnosis of PKAN confirmed by MRI and gene testing
  • able to undergo MRI for approximately 1 hour without sedation

Exclusion Criteria:

  • deep brain stimulators or other conditions that warrant avoidance of a strong magnetic field
  • previous reaction to gadolinium (Gd) contrast agent
  • acute or chronic kidney dysfunction
  • pregnant and/or nursing at time of study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838018


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Susan J. Hayflick
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Investigators
Principal Investigator: Susan J Hayflick, MD Oregon Health and Science University

Additional Information:
Responsible Party: Susan J. Hayflick, Professor & Chair, Molecular & Medical Genetics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01838018     History of Changes
Other Study ID Numbers: 8777
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Keywords provided by Susan J. Hayflick, Oregon Health and Science University:
PKAN
brain iron
NBIA
neurodegeneration with brain iron accumulation
Hallervorden Spatz Syndrome

Additional relevant MeSH terms:
Nerve Degeneration
Pantothenate Kinase-Associated Neurodegeneration
Brain Diseases
Pathologic Processes
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroaxonal Dystrophies
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn