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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06177626
Other study ID # AAAV0188 (Aim 3)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date September 1, 2026

Study information

Verified date December 2023
Source Columbia University
Contact Scott Barbuto, MD, PhD
Phone 212-305-3535
Email sb3779@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this project is to evaluate how aerobic training impacts eyeblink conditioning as a proxy for cerebellar dependent motor learning. The newly developed smartphone application, iBlink, will be used to test participants at home in an effort to improve recruitment and increase the sample size of the study. The investigators hypothesize that aerobic training, but not balance training, will improve eyeblink conditioning in participants with spinocerebellar ataxias. The current study focuses on Aim 3 of this project.


Description:

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Study Design


Intervention

Behavioral:
Aerobic Training
Aerobic training on stationary bike 5x a week for 30 minutes a day
Balance Training
Training 5x a week for 30 minutes. Standard of care.

Locations

Country Name City State
United States Columbia University/New York Presbyterian New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Conditioned Response (CR) Amplitude Individual eyelid traces will be normalized by dividing each trace by the maximum signal amplitude of the relevant session. Thus, eyes closed will correspond to a value of 1, and eyes open to a value of 0. A mean baseline Conditioned Response (CR) amplitude will be determined for each participant using the pre-block Conditioned Stimulus (CS) only trials. CR amplitude will then be determined as the maximum signal amplitude value at 430ms, for paired and CS only trials, minus the baseline CR amplitude. 0, 3, 6, and 9 months
Secondary SARAhome Score Scale for the Assessment and Rating of Ataxia Home (SARAhome) is a validated home measurement of ataxia symptoms with the participants recording 5 tasks (gait, stance, speech, nose-finger test, and fast alternating hand movements) with a smartphone. Scores range from 0 to 28 with higher scores indicating more ataxia symptoms. SARAhome and the conventional SARA were shown to be highly correlated, and this measurement was deemed reliable for home monitoring of ataxia symptoms. Scores will be used to correlate with changes in eyeblink conditioning as a result of training. 0, 3, 6, and 9 months
Secondary PROM of Ataxia Score The Patient Reported Outcome Measure (PROM) of Ataxia is a 70-item survey that is scored by participants on a 0-4 Likert scale. It asks participants to rate motor domains of gait, lower and upper extremity control, manual dexterity, visual motor control, dysphagia, bowel and bladder function, sleep, fatigue, vertigo, libido, neuropathy, ability to do household chores, driving, self-care, mood, anxiety, motivation, and social interactions. Scores will be used to correlate with changes in eyeblink conditioning as a result of training. Scores range from 0-280 with a higher score indicating a worse outcome. 0, 3, 6, and 9 months
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