This is an observational study. Subjects with a documented diagnosis of spinocerebellar ataxia (SCA) will be screened and recruited to participate at two clinical sites: Johns Hopkins University (JHU) and Columbia University (CU).
Researchers at BioSensics, JHU, and CU will use wearable sensors computerized speech, psychomotor, and ocular assessments to evaluate the feasibility of using digital health technologies to monitor symptoms in SCA. Researchers will also measure the Scale for the Assessment and Rating of Ataxia (SARA) and other SCA clinical assessments.
The solution will be deployed for 25 participants with SCA for approximately 12 months with 5 study visits (Screening/Baseline, Day 1, Day 30, Day 90, Day 180, Day 360).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female, aged 18-75 years
* Fluent in English (able to speak and read)
* Able to ambulate at least 10 meters independently or with a cane, without other assistive devices, as determined by the investigator
* Able to independently perform all study activities safely, as determined by the investigator
* Willing and able to provide informed consent and comply with all study procedures
* Genetically or clinically confirmed diagnosis of spinocerebellar ataxia (SCA 1, 2, 3, or 6)
Exclusion Criteria:
* Individuals who are unable to ambulate at least 10 meters independently or with a cane.
* Individuals with a neurological, medical, or psychiatric condition (other than SCA) that, in the investigator's judgment, would interfere with safe participation in study activities or confound the assessment of ataxia
* Pregnant individuals, due to potential changes in gait and physical activity during pregnancy
* Any condition that, in the investigator's judgment, would prevent the participant from completing the study procedures safely
Primary outcome measure(s)
Physical Activity Monitoring - Daily Number of Steps (count) — 12 months Following each clinical visit, participants will be asked to wear a PAMSys pendant sensor, PAMSys ULM wrist sensors, and PAMSys Gait for 7 days at home. The average daily number of steps will be measured using the PAMSys pendant.
Physical Activity Monitoring - Total number of goal-directed movement (GDM) — 12 months Following each clinical visit, participants will be asked to wear a PAMSys ULM sensor, a wearable sensor for long-term monitoring of upper limb and activities of daily living (ADL). The sensor will record the daily number GDMs as participants perform ADLs.
Physical Activity Monitoring - Stride Velocity (m/s) — 12 months Following each clinical visit, participants will be asked to wear a PAMSys Gait sensor, a wearable sensor for long-term monitoring of gait during activities of daily living (ADL). The sensor will record the average stride velocity (m/s) during ADLs.
Trial sites (2)
Facility
City
Region
Status
Johns Hopkins University School of Medicine
Lutherville
Maryland
Columbia University Irving Medical Center/Neurological Institute of New York
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
