Trial record 1 of 5 for:    Neurodegeneration with Brain Iron Accumulation
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Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Oregon Health and Science University
Sponsor:
Collaborators:
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
Susan J. Hayflick, Oregon Health & Science University
ClinicalTrials.gov Identifier:
NCT01838018
First received: April 18, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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
Pantothenate Kinase-associated Neurodegeneration (PKAN)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Brain Perfusion in Pantothenate Kinase-Associated Neurodegeneration (PKAN)

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • ASL-derived cerebral blood flow(CBF) [ Time Frame: Single MRI ] [ Designated as safety issue: No ]
    The unit of analyses will be the subject and the primary comparison will be the globus pallidus CBF between PKAN and healthy controls.


Estimated Enrollment: 12
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   7 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: April 18, 2013
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
PKAN
brain iron
NBIA
neurodegeneration with brain iron accumulation
Hallervorden Spatz Syndrome

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

ClinicalTrials.gov processed this record on August 28, 2014