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

NCT07315984 | Not Yet Recruiting

• 2 other identifiers: BioDigit HD-021R44TR005381-01A1
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Huntington Disease

Keywords

huntington disease; wearable sensors; digital health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

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

  12 months

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

  12 months

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

  12 months

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

  12 months

• Change in the Montreal Cognitive assessment (MoCA) score

  12 months

Other Outcomes (3)

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

  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

  12 months

• Change in the Verbal Fluency test score

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ana Enriquez

CONTACT

888-589-6213; ana.enriquez@biosensics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 5, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)