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Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)

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ClinicalTrials.gov Identifier: NCT01838018
Recruitment Status : Recruiting
First Posted : April 23, 2013
Last Update Posted : September 28, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Brain Perfusion in Pantothenate Kinase-Associated Neurodegeneration (PKAN)
Study Start Date : April 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017


Groups and Cohorts

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.


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Senior)
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
Contacts and Locations

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


Contacts
Contact: Allison M Gregory, MS 503-494-4344 gregorya@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Allison M Gregory, MS    503-494-4344    gregorya@ohsu.edu   
Principal Investigator: Susan J Hayflick, MD         
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
More Information

Additional Information:
Responsible Party: Susan J. Hayflick, Professor & Chair, Molecular & Medical Genetics, Oregon Health & 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: September 28, 2016
Last Verified: September 2016

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

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