Instrumented Data Exchange for Ataxia Study (NCT04268147) | Clinical Trial Compass
CompletedNot Applicable
Instrumented Data Exchange for Ataxia Study
United States128 participantsStarted 2019-06-01
Plain-language summary
This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of ataxia.
Who can participate
Age range
12 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* SCA 1, 2, 3, 6, and FA with mutations in the pathogenic range confirmed from genetic testing
* SCA: aged 18-75 years
* FA: aged 12-30, diagnosed between ages 5-25
* community dwelling
* physically/cognitively capable of consenting/assenting and complying with the protocol based on investigator's judgement
* able to walk independently 10 yards without an assistive device
* able to sit or stand unassisted for 30 seconds
* no other neurological or musculoskeletal disorder that could affect mobility
* no other history of head injury, vestibular function, stroke, or other disorders that could affect mobility
* willing and able to participate in a 2-year study
* consent to be video recorded while performing study assessments
Exclusion Criteria:
* dementia that limits subjects' ability to follow directions
* pain that limits mobility
* SCA: enrolled in a clinical drug trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.