Measuring Neurological Impairment and Functional Visual Assessment In Spinocerebellar Ataxias

This study has been completed.
Sponsor:
Collaborator:
University of Texas
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00654251
First received: April 1, 2008
Last updated: April 28, 2009
Last verified: April 2009

April 1, 2008
April 28, 2009
February 2008
February 2009   (final data collection date for primary outcome measure)
Home based gait data vs SARA index [ Time Frame: 0, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00654251 on ClinicalTrials.gov Archive Site
  • Barthel Index [ Time Frame: 0, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Visual function- acuity, contrast, stereo, color [ Time Frame: 0, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Ocular Motility defects- phoria/tropia, vergence amplitudes [ Time Frame: 0, 6, 12, 24 months ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Measuring Neurological Impairment and Functional Visual Assessment In Spinocerebellar Ataxias
Utility Of Home Based Gait Monitoring, Performance Scores And Functional Visual Assessment In Spinocerebellar Ataxias (SCA)

Measuring the various difficulties patients with spinocerebellar ataxias (SCA) report in an accurate manner is important to be able to test any therapy that may be developed. As basic research identifies some therapy of this type, clinicians are planning studies that can either prove or disprove that such treatments actually have an effect. Walking problems and problems with eye movements that can give rise to visual complaints are common in the SCA's.

Existing neurological scales such as the "SARA" are based on the usual neurological examination items that can carry a degree of subjective bias. Also the intervals between numbers on such scores often do not carry the same "weight" so that the difference between a score of 1 and 2 may not be equal to difference between 2 and 3. Lastly, such scales done in the clinic setting capture only a brief period of a patient's day. We propose that examination of home based gait monitoring, timed tests of motor function and quantitative measures of visual problems in patients with SCA are more useful in measuring the disability in these patients.

Spinocerebellar ataxias (SCA's) are relatively rare, inherited disorders of the cerebellum that cause inexorably progressive imbalance and incoordination as well as speech problems. Recent molecular genetic studies have raised hopes for meaningful treatments for these conditions. Before one can embark on therapeutic studies on the SCA's it is essential that we have validated instruments for measuring disease progression. Rating scales based on neurological examinations have been reported recently but their sensitivity to change and reproducibility are still being examined. In an attempt to produce readily quantifiable and sensitive measures of motor function in the SCA's, we are proposing to examine the utility of home based gait monitoring, timed tests of motor function and quantitative measures of visual problems in patients with SCA's. These measurements which will produce continuous rather than categorical variables, and may be subject to less arbitrariness on the part of the examiner, are hypothesized to be not only valid measures but also more sensitive.

The overall aim of the project is to assess the utility of home based gait monitoring, timed performance measures and functional visual testing as measures to monitor disease progression in SCA's. The concurrent validity of these measures will be tested by correlating them with an established examination based ataxia scale (Scale for assessment and rating of ataxia: SARA), an activity of daily living scale (Barthel index) and functional staging.

Aim 1: Hypothesis: Motor impairment in SCA's can be assessed validly in the home setting by utilizing the step activity monitor (SAM).

Aim 2: Hypothesis: Motor impairment in SCA's can be further quantified using performance measures: the 9-hole peg board test and the timed 25 foot walk.

Aim 3: Hypothesis: Visual problems reported by patients with SCA's can be quantified by low contrast vision testing, stereoacuity measures, color vision and vergence amplitudes utilizing well-established ophthalmologic techniques.

Aim 4: Hypothesis: The neurological impairment as measured by these measures will correlate with each other, with scores on SARA, with the Barthel index score and with functional staging.

Aim 5: Hypothesis: Ataxia grading using the SAM, timed performance measures and functional visual scores will be more sensitive than SARA for measuring disease progression

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients attending the Ataxia Clinic

Spinocerebellar Ataxia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with the diagnosis of Spinocerebellar Ataxia (Type 1,2,3,6,7,8 and 10) will be selected from those attending the ataxia clinic in the Neurology Department at University of Mississippi Medical Center
  2. Patients will be 18years or older in age
  3. All patients are able to walk with or without assisted devices

Exclusion Criteria:

  1. Patients less than 18years.
  2. Patients who are wheelchair bound
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00654251
2007-0228
No
James J Corbett, University of Mississippi Medical Center
University of Mississippi Medical Center
University of Texas
Study Chair: James J Corbett, MD University of Mississippi Medical Center
Study Director: S H Subramony, MD University of Texas
Study Director: Sachin Kedar, MD University of Mississippi Medical Center
University of Mississippi Medical Center
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP