Multi-Modal Digital Monitoring of Disease Symptoms Huntington's Disease (BioDigit HD-02)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Huntington Disease

Detailed Description

HD is a devastating inherited neurological disorder that causes progressive nerve degeneration in the brain. HD is characterized by multifaceted symptomatology including motor, cognitive, and psychiatric symptoms, which begin insidiously and progress over many years. The principal means of measuring gross motor and speech impairment in HD is the Unified Huntington's Disease Rating Scale (UHDRS). Although valuable, the scale is subjective and categorical and requires significant training to administer correctly. Quantitative motor (Q-motor) tests have helped reduce subjectivity and improve sensitivity of motor assessments in HD. Q-Motor assessments have demonstrated utility in tracking longitudinal progression of motor impairment and as a supplemental measure in clinical trials. Likewise, force-sensitive insoles, video motion analysis systems, and pressure-sensitive walking mats have been utilized to objectively measure impaired gait in HD. However, these gait-measuring technologies and Q-Motor assessments must be administered in clinic by trained personnel. Similarly, the Montreal Cognitive assessment (MoCA) and Mini-mental State Examination, are often used to measure cognitive decline. However, these tests need to be administered by trained professionals and have limited ability to detect subtle changes in cognitive performance over time. Furthermore, measures are conducted infrequently, typically in a clinic setting, and may not be an accurate representation of an individual's true cognitive status.

There is currently no cure which can halt, slow or reverse the progression of the disease. The key challenge in development of new therapeutics in HD and other neurological disorders is that the current way of assessing the disease is largely subjective and requires in-person, in-clinic assessments. Digital measures, like the proposed solution can provide objective, real-world assessments of how individuals are functioning.

Wearable sensors and digital health technologies that can detect motor, speech, and cognitive abnormalities can provide insight into the phase of clinical disease onset. Given that gene positive premanifest stage of HD can take up to several years before the onset of symptomatic disease, the subtle changes in these biomarkers in the early stage of HD provide an opportune window to apply disease-modifying treatment that could potentially slow down or prevent the progression of the disease

Thus, a system that can objectively, sensitively, and frequently monitor multiple clinical domains (motor, speech and cognitive function) is necessary to understand the pattern of evolving motor, speech and cognitive abnormalities in individuals with prodromal HD, and for identification of endpoint measures for therapeutic trials.

This observational study will follow participants over 12 months. 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. In addition to standard clinical assessments, the study will leverage BioDigit HD to collect wearable and digital health data from participants in at the study site and their home environments.

A key objective of the project is to measure changes in disease symptoms using patient reported outcomes (PROs), clinical reported outcomes, and digital measures in individuals with HD.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Ana Enriquez; Phone Number: 502 888-589-6213; Email: ana.enriquez@biosensics.com

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
      • Contact: Jamie Adams, MD; Email: Jamie_Adams@urmc.rochester.edu
      • Principal Investigator: Jamie Adams, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
      • Principal Investigator: Daniel Claassen
      • Contact: Daniel Claassen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.
• 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.

For control participants:

• Male or female, aged 25-65 years
• Clinically assessed to be in good health, with no evidence of neurological disorders that could cause involuntary movements or gait disturbances

Exclusion Criteria:

• 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
• Pregnant individuals, due to potential changes in gait and physical activity during pregnancy.
• Cannot be enrolled into a blinded intervention trial at baseline.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hungtinton's Disease; Participants with clinical diagnosis of HD
Age-matched healthy adults; Age-matched healthy adults. Clinically assessed to be in good health, with no evidence of neurological disorders that could cause involuntary movements or gait disturbances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Total Motor Score: Scores range from 0 to 124. Higher scores represent a worse outcome.; Total Functional Capacity: Scores range from 0 to 13. Lower scores represent a worse outcome.; Behavioral Assessment: Scores range from 0 to 88. Higher scores represent a worse outcome.; Cognitive Assessments: Inclues Stroop test, Verbal Fluency, and Symbol Digit Modalities Test. Lower scores represent a worse outcome.	12 months
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.	12 months
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.	12 months
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.	12 months
Change in the Montreal Cognitive assessment (MoCA) score	The MoCA will be assessed from participants during baseline, 3 month, 6 month, 9 month and 12 month visits.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: BioSensics
• Collaborators: Vanderbilt University Medical Center; National Center for Advancing Translational Sciences (NCATS); University of Rochester - CHeT/CTCC

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: digital health; wearable sensors; huntington disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurocognitive Disorders; Cognition Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Dyskinesias; Chorea; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Huntington Disease
• Other Study ID Numbers: BioDigit HD-02; 1R44TR005381-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No