Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03885167 |
Other study ID # |
HUM00121991 |
Secondary ID |
U01NS106670 |
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 21, 2019 |
Est. completion date |
January 4, 2023 |
Study information
Verified date |
November 2023 |
Source |
University of Michigan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The purpose of this study is to examine the differences in cerebral spinal fluid (CSF) and
blood of patients with spinocerebellar ataxias and healthy volunteers. The goal of this
project is to identify new biomarkers that are useful for characterizing spinocerebellar
ataxias and identify targets for treatment or prevention of this condition.
Description:
Participants will undergo a SARA exam, a lumbar puncture and a blood draw. A lumbar puncture
is a procedure in which a small amount of the spinal fluid that surrounds the brain and
spinal cord is removed by inserting a needle in the lower back. Participants will be asked
not to eat or drink anything (water is acceptable) for at least 6 hours before the lumbar
puncture visit. For this procedure, participants will be positioned lying on their side and
curled up in a ball, or sitting up and bent forward, whichever is easier. Cushions will be
used to enhance comfort. The lower back region will be cleaned and disinfected with an
antiseptic iodine solution. The doctor will inject local anesthetic (lidocaine, 1%) into the
skin of the lower back. This may produce a transient, mild burning sensation. A very small
needle will be introduced into the skin and moved into fluid-filled space around the spinal
nerves coming from the spinal cord. This may produce a pressure sensation. Approximately 2
tablespoons approximately 30 ml) of fluid will be collected. The needle will be removed and a
band-aid applied over the needle insertion site. Participants will be asked to remain
stationary, lying on flat for about ½ hour on a bed in the research clinic. Participants will
be given something to eat and drink before leaving. Strenuous physical activity should be
avoided for the next 24 hours. This includes lifting, bending, doing housework and gardening,
or doing exercise such as jogging or bicycle riding. The SARA (Scale for the Assessment and
Rating of Ataxia) exam is a clinical scale that assesses a range of different impairments in
cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech,
fingerchase test, nose-finger test, fast alternating movements and heel-shin test, and takes
approximately 15 minutes to complete.
The study also involves a single collection of about 3.5 tablespoons (approximately 50 ml) of
blood. This blood draw may take place during a regularly scheduled visit to the neurology
clinic or at the research appointment.