Multi-Modal Digital Monitoring of Disease Symptoms Huntington's Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-65
SponsorBioSensics

About this trial

The objective of the study is to validate the use of wearable sensors and digital health technologies for monitoring disease activity in Huntington's Disease (HD). Healthy subjects, as well as subjects with documented diagnosis of HD will be screened and recruited at University of Rochester Medical Center and Vanderbilt University Medical Center to participate in this 12-month observational study. There will be a total of 5 visits every approximately 3 months.

In each study visit, participants will complete several Patient Reported Outcomes (PROs), Clinical Reported Outcomes, complete a series of Digital Assessments (Speech, Cognitive, Motor, and Finger Tapping). Participants will be provided with a pendant, wrist, and ankle sensors to monitor their daily physical activities for 7 days after each study visit. Participants will also be provided with a tablet to complete digital assessments (Speech, Cognitive, Motor, and Finger Tapping) on monthly basis at home.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female, aged 25-65 years

For HD participants: Genetically diagnosed with HD

Fluent in English (able to speak and read).

Ambulatory without the need for a walking aid.

Disqualifiers

Diagnosis of juvenile-onset HD.

Individuals who are non-ambulatory.

Individuals with a neurological, medical, or psychiatric condition that, in the investigator's judgment, would interfere with safe participation in study activities.

Montreal Cognitive Assessment (MoCA) score of 18 or lower

Trial population

Adults with clinical diagnosis of HD, and healthy age-matched controls

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

75 Participants
are grouped into 2 trial groups
Group A: Hungtinton's Disease
Group B: Age-matched healthy adults

Trial outcomes

Primary outcomes

1

Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant

Daily walking duration (hours) will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits.

Time frame
12 months
2

Change in daily number of sit to stand transitions (count) during activities of daily living from baseline to 12 months as measured by the PAMSys pendant.

Daily number of sit to stand transitions will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits.

Time frame
12 months

Secondary outcomes

1

Change in scores of Unified Huntington's Disease Rating Scale (UHDRS) from baseline to 12 months

A clinical tool used to assess motor, cognitive, and behavioral symptoms in individuals with Huntington's disease (HD). There are 5 parts to UHDRS 1. Total Motor Score: Scores range from 0 to 124. Higher scores represent a worse outcome. 2. Total Functional Capacity: Scores range from 0 to 13. Lower scores represent a worse outcome. 3. Behavioral Assessment: Scores range from 0 to 88. Higher scores represent a worse outcome. 4. Cognitive Assessments: Inclues Stroop test, Verbal Fluency, and Symbol Digit Modalities Test. Lower scores represent a worse outcome.

Time frame
12 months
2

Change in intelligibility when reading a standard Rainbow passage from baseline to 12 months as measured by BioDigit Speech

Speech data will be collected from participants while reading a standard Rainbow passage on a monthly basis for 12 months. BioDigit Speech, and automatic speech analysis software, will be used to analyze the collected speech data to calculate intelligibility of speech during reading a standard Rainbow passage.

Time frame
12 months
3

Change in walking speed during activities of daily living from baseline to 12 months as measured by the PAMSys Ankle sensor

median, 90 percentile and 96 percentile stride velocity (m/s) will be measured by the PAMSys Ankle sensor. PAMSys Ankle sensor will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits.

Time frame
12 months
4

Change in cadence during activities of daily living from baseline to 12 months as measured by the PAMSys pendant

Median, 90 percentile and 96 percentile cadence (steps/min) will be measured by the PAMSys pendant. PAMSys pendant will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits.

Time frame
12 months

Other outcomes

1

Change in tapping rate (number of taps per minute) from baseline to 12 months as measured by the BioDigit Clinic and BioDigit Home tablets

Finger tapping test will be collected from participants on a monthly basis for 12 months.

Time frame
12 months
2

Change in daily number of hand goal-directed movements during activities of daily living from baseline to 12 months as measured by the PAMSys ULM wrist sensor

PAMSys ULM wrist sensor measures goal directed movements of the hand during activities of daily living. PAMSys ULM wrist sensors will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits.

Time frame
12 months
3

Change in the Verbal Fluency test score

Verbal fluency test data will be collected at baseline, 3 month, 6 month, 9 month and 12 month visits.

Time frame
12 months

Sponsors and contacts

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

BioSensics

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

University of Rochester - CHeT/CTCC

Collaborator

Vanderbilt University Medical Center

Collaborator

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