Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease
|ClinicalTrials.gov Identifier: NCT01451463|
Recruitment Status : Completed
First Posted : October 13, 2011
Results First Posted : October 19, 2017
Last Update Posted : November 24, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
U.S. FDA Resources
- Tinetti Mobility Test Score [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for >18 hours with the performance two hours after resuming tetrabenazine was made.
- Five Times Sit to Stand Test [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]Subjects are asked to sit in a chair with their arms across their chests and asked to stand and sit five times in a row. The time it takes to complete 5 sit to stand cycles is timed with a stop watch. Comparison is made when off stable dose of tetrabenazine for >18 hours to performance 2 hours after resumption of tetrabenazine. Lower time scores are associated with better balance.
- Six Condition Romberg Test [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]The Six Condition Romberg Test is used assess static balance. Subjects are tested standing with their arms crossed over their chests and are assessed for 30 seconds in the following 6 conditions: 1) feet together, 2) feet together eyes closed, 3) feet aligned in tandem heel-to-toe position eyes open, 4) feet aligned in tandem heel-to-toe position eyes closed, 5) standing in tandem position while counting backwards by 3's from 100 with eyes open, 6) standing in tandem position while counting backwards by 3's from 100 with eyes closed. Comparison of performances were made when off stable dose of tetrabenazine for > 18 hours to performance 2 hours after resumption of tetrabenazine. If a participant could not hold a stance for the full 30 seconds, then that component of the Romberg test ended at that point with the time of that component scored in seconds; 30 seconds being the maximum score for each of the 6 tests. The total score was calculated as a sum of all of the 6 subset scores.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|