Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease
In individuals with Huntington's disease (HD), chorea may contribute to balance problems and difficulties with walking, sit to stand transfers and stair climbing that in turn may contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that is commonly used to reduce chorea.
The purpose of this study is to compare: 1) spatial and temporal gait measures, 2) performance on functional mobility measures, and 3) amount of daily walking activity before and after administration of Xenazine in individuals with HD. It is hypothesized that the use of Xenazine to decrease chorea will improve functions of 1) gait, 2) sit-to-stand transfers 3) stair climbing and 4) overall daily physical activity and function.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease|
- Tinetti Mobility Test Score [ Time Frame: 0-20 hours ] [ Designated as safety issue: No ]Comparison of scores off regular stable dose of tetrabenazine for 18 hours with performance two hours after resuming tetrabenazine
- Timed Sit to Stand Test [ Time Frame: 0-20 hours ] [ Designated as safety issue: No ]Comparison off stable dose of tetrabenazine for 18 hours to performance two hours after resumption of tetrabenazine
- Six component Romberg Test [ Time Frame: 0-20 hours ] [ Designated as safety issue: No ]Comparison of performance when off stable dose of tetrabenazine for 20 hours to performance 2 hours after resumption of tetrabenazine.
|Study Start Date:||April 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Individuals with HD who are ambulatory and are either already taking Xenazine or have been newly prescribed the medication will be recruited for this prospective open-label study. A variety of motor assessments will be preformed while subject are taking Xenazine or after a period off of the medications. These tests include: Unified Huntington's Disease Rating Scale (UHDRS) motor section, GAITRite forward walking, Tinetti Mobility Test, Timed Sit-to-Stand Test, Timed Stair Climb Test, Rhomberg test. A subset of subjects will wear an activity monitoring device on the wrist of the non-dominant hand for 5 consecutive days and nights.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451463
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Sandra K Kostyk, MD,PhD||Ohio State University|