Brain Perfusion in Pantothenate Kinase-associated Neurode... | NCT01838018

Studies
Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)

NCT01838018

Sponsor

Susan J. Hayflick

Status

Completed

Last Update Posted

May 29, 2018Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Pantothenate Kinase-associated Neurodegeneration (PKAN)

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013Actual

Primary Completion Date

Oct 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

Apr 18, 2013

First Submission Date that Met QC Criteria

Apr 22, 2013

First Posted Date

Apr 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2018

Last Update Posted Date

May 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Susan J. Hayflick, Professor & Chair, Molecular & Medical Genetics, Oregon Health and Science UniversitySponsor-Investigator

Lead Sponsor

Susan J. HayflickOTHER

Collaborators

Name	Class
Oregon Health and Science University	OTHER
Oregon Clinical and Translational Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ASL-derived cerebral blood flow(CBF)	The unit of analyses will be the subject and the primary comparison will be the globus pallidus CBF between PKAN and healthy controls.	Single MRI

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The PKAN group consists of individuals in the United States diagnosed with PKAN.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan J Hayflick, MD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D006211	Pantothenate Kinase-Associated Neurodegeneration

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided