Huntington DiseaseBioDigit HD-02NCT07315984
Multi-Modal Digital Monitoring of Disease Symptoms Huntington's Disease
An observational study of Huntington Disease, run by BioSensics at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2027to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with clinical diagnosis of HD, and healthy age-matched controls
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Daniel Claassen, MD
Daniel Claassen
University of Rochester Medical Center
Rochester, New York, 14642
Jamie Adams, MD, Jamie_Adams@urmc.rochester.edu
Jamie Adams, MD
About this study
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.
Read the 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.
- Conditions
- Huntington Disease
- Keywords
- huntington disease, wearable sensors, digital health
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start31 Jan 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), University of Rochester - CHeT/CTCC, Vanderbilt University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315984
- Sponsor's protocol ID
- BioDigit HD-02
- Other IDs
- 1R44TR005381-01A1
- Acronym
- BioDigit HD-02
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modal Digital Monitoring of Disease Symptoms Huntington's Disease
- ClinicalTrials.gov ID
- NCT07315984
- Acronym / sponsor ID
- BioDigit HD-02 / BioDigit HD-02
- Conditions
- Huntington Disease
- Keywords
- huntington disease, wearable sensors, digital health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- BioSensicsIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), University of Rochester - CHeT/CTCC, Vanderbilt University Medical Center
- Study start
- 31 Jan 2027 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with clinical diagnosis of HD, and healthy age-matched controls
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant
Time frame: 12 months
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.
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.
Time frame: 12 months
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.
5 secondary outcomes
Change in scores of Unified Huntington's Disease Rating Scale (UHDRS) from baseline to 12 months
Time frame: 12 months
Change in intelligibility when reading a standard Rainbow passage from baseline to 12 months as measured by BioDigit Speech
Time frame: 12 months
Change in walking speed during activities of daily living from baseline to 12 months as measured by the PAMSys Ankle sensor
Time frame: 12 months
Change in cadence during activities of daily living from baseline to 12 months as measured by the PAMSys pendant
Time frame: 12 months
Change in the Montreal Cognitive assessment (MoCA) score
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Huntington Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 3
Pridopidine Phase 3 Study in Huntington's Disease
Huntington Disease
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by BioSensics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Enriquez (888-589-6213 ext. 502, ana.enriquez@biosensics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.