Multi-Modal Digital Monitoring of Disease Symptoms in Spinocerebellar Ataxia

ConditionSpinocerebellar Ataxia (SCA)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorBioSensics

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adults with SCA

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

Physical Activity Monitoring - Daily Number of Steps (count)

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.

Time frame

12 months

Physical Activity Monitoring - Total number of goal-directed movement (GDM)

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.

Time frame

12 months

Physical Activity Monitoring - Stride Velocity (m/s)

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.

Time frame

12 months

Secondary outcomes

Scale for the Assessment and Rating of Ataxia (SARA)

The SARA is an 8-item clinical sale to measure severity and progression of cerebellar ataxia. Total scores range from 0 (no ataxia) to 40 (most severe ataxia).

Time frame

12 months

Digital Speech Assessment - Intelligibility (%)

Using a study tablet, participants will read the Rainbow Passage. Intelligibility is a digital measure of speech clarity that determines how easily a listener can understand spoken words. Intelligibility ranges scores from 0 to 100%

Time frame

12 months

1 Minute Walk Test - Gait Speed (m/s)

Performed at each clinical visit, the participant will complete the 1 Minute Walk Test. Gait speed will be measured using LEGSys.

Time frame

12 months

Digital Occulomotor Assessments - Median velocity (pixel/s)

Using a study tablet, participants will perform a series of oculomotor assessments (saccades). The video will be analyzed to calculate the median velocity of the pupil during saccade movements.

Time frame

12 months

Other outcomes

Digital Fine Motor Control Assessment - Number of taps (count)

Using a study tablet, participants will perform a series of tapping tests. The tablet will calculate the count of all recorded taps made by a finger on the screen.

Time frame

12 months

Digital Fine Motor Control Assessment - Average tap rate (s)

Using a study tablet, participants will perform a series of tapping tests. The tablet will calculate the number of taps per second.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioSensics

Lead sponsor

Source ClinicalTrials.gov

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