Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01873924
Status:
RECRUITING
Last Update Posted:
2023-07-17
First Post:
2013-05-17
Brief Title:
Clinical and Neuropsychological Investigations in Batten Disease
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Clinical and Neuropsychological Investigations in Batten Disease
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess the natural history of Batten disease Neuronal Ceroid Lipofuscinosis by obtaining information about the motor behavioral and functional capabilities of individuals with Batten disease This study will also refine and validate the Unified Batten Disease Rating Scale UBDRS as a clinical rating instrument for Batten disease
Detailed Description:
Batten Disease is an inherited disorder that causes progressive cognitive and behavioral decline in children There have been no systematic clinical studies of Batten Disease using standardized rating instruments with known inter-rater reliability and validity
The Batten Study Group developed the Unified Batten Disease Rating Scale UBDRS a clinical rating instrument used to assess the motor behavioral and functional capabilities of individuals with Batten disease Using the UBDRS study investigators will evaluate participants approximately every year to track disease progression The UBDRS is the primary natural history tool but the study also includes neuropsychological assessment adaptive function quality of life measures and other measures to assess the impact of Batten Disease Participants will be examined at the University of Rochester Batten Center Batten Disease Support and Research Association annual meeting or remotely via televideo Information related to racial and ethnic background medical history symptoms medications and diagnostic testing will be collected
The Batten Study Group developed the Unified Batten Disease Rating Scale UBDRS a clinical rating instrument used to assess the motor behavioral and functional capabilities of individuals with Batten disease Using the UBDRS study investigators will evaluate participants approximately every year to track disease progression The UBDRS is the primary natural history tool but the study also includes neuropsychological assessment adaptive function quality of life measures and other measures to assess the impact of Batten Disease Participants will be examined at the University of Rochester Batten Center Batten Disease Support and Research Association annual meeting or remotely via televideo Information related to racial and ethnic background medical history symptoms medications and diagnostic testing will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None