Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease

Completed

• Conditions: Huntington's Disease

• Registration Number: NCT01451463
• Lead Sponsor: Ohio State University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-13
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2016-04-23
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-17
• Results First Posted: 2017-10-19
• Last Update Submitted: 2017-10-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Huntington's Disease
• Able to ambulate independently

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Exclusion Criteria

• Other orthopedic or neurological disorder that affects gait or balance
• Pregnancy
• Chorea score <10 prior to initiation of medication.
• Inability to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tinetti Mobility Test Score	>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.

Secondary Outcome Measures

Name	Time	Method
Five Times Sit to Stand Test	>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.

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States