Therapeutic area
Progressive supranuclear palsy
Developing digital measures of daily function in PSP and studying their potential to support earlier diagnosis.
Progressive supranuclear palsy (PSP) is a rare, progressive neurological disorder that affects balance, movement, eye movements, speech, and swallowing. Changes in thinking and behavior can also occur. Symptoms reflect damage to nerve cells in brain regions involved in movement and cognition.
PAMSys accepted into the FDA ISTAND program for PSP trials
FDA has accepted PAMSys into the FDA ISTAND program as a drug development tool for measuring ambulation in progressive supranuclear palsy (PSP) clinical trials. The Letter of Intent for BioDigit Speech measures in PSP has been accepted for review.
Our research in PSP
Our PSP research focuses on three complementary areas: evaluating digital measures of symptoms and function, exploring features that may help distinguish PSP from related disorders, and building longitudinal research datasets.
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Digital symptom measures
Digital measures of PSP symptoms
Wearable recordings and digital assessments characterize movement, speech, cognition, and daily function over time.
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Early diagnosis
Exploring digital markers of PSP
Studying speech and gait features that may help distinguish PSP from Parkinson's disease and related disorders.
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Longitudinal datasets
Longitudinal datasets for PSP research
Repeated assessments from our PSP studies build datasets for studying daily function alongside clinical outcomes.
Digital measures of PSP symptoms
Our research combines wearable recordings and digital assessments to characterize PSP symptoms and daily function. Developed with clinical experts and informed by participant experience, these measures cover motor, speech, cognitive, and related functional domains. We evaluate their accuracy and their relationship to established clinical assessments.
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PAMSys and PAMSys Fall
Wearable sensors record activity and mobility, while PAMSys Fall identifies potential falls for review.
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PAMSys ULM
Wrist-worn sensors record upper-limb movement. Algorithms identify patterns consistent with goal-directed use during daily activities.
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LEGSys
Wearable sensors quantify walking parameters during structured gait assessments, including remotely supervised testing at home.
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BioDigit Speech
Standardized speech tasks and automated analysis characterize features of speech affected by dysarthria.
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Cognitive and fine motor assessments
Tablet-based cognitive tasks and fine motor tests support repeated assessment at home.
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Oculomotor assessments
Standardized video tasks capture visible eye movements for research into oculomotor function using BioDigit Video.
Exploring digital markers of PSP
PSP can resemble Parkinson's disease and other related disorders, particularly early in its course. We study speech and gait features that differ between these conditions and may contribute to future diagnostic tools. Their usefulness for earlier diagnosis requires further evaluation.
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Speech analysis
Automated analysis of speech features explores patterns that may help distinguish PSP from Parkinson's disease.
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Wearable gait assessment
Remotely supervised gait assessments quantify walking characteristics and examine differences between PSP and Parkinson's disease.
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Multimodal differentiation
Research combines speech, gait, and other digital measures to evaluate their potential contribution to differential diagnosis.
Analytical validation of our digital measures in PSP
We compare automated scores with expert ratings to evaluate measurement accuracy. Speech intelligibility findings are reported in the published Frontiers article; verbal fluency analyses remain preliminary. BioDigit PSP3 (NCT07240805) is designed to evaluate wearable measures of physical activity, gait, and upper-limb movement.
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Speech intelligibility
In 49 participants with PSP, BioDigit Speech intelligibility scores from standardized passage reading were compared with the mean ratings of three experts. For native speakers, r = 0.90 and ICC = 0.84; automated scores were systematically lower.
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Verbal fluency
In a preliminary, unpublished analysis of 41 people with PSP, categorical and phonemic fluency tasks were completed remotely on BioDigit Home and scored with BioDigit Speech. Automated word counts agreed with blinded expert scoring, with r = 0.93 to 0.97 and ICC = 0.96 to 0.98.
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Physical activity and upper-limb function
BioDigit PSP3 is designed to compare PAMSys, PAMSys Gait, and PAMSys ULM measures with structured motor assessments at Massachusetts General Hospital and Johns Hopkins University.
Evaluating clinical validity in PSP
Longitudinal studies examine whether digital measures reflect changes in symptoms and function over time. Research evaluates associations between speech, verbal fluency, physical activity, and clinical outcomes. Results support further validation for specific research uses, including measurement of change and exploratory prediction.
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Speech
A published study followed 32 native English-speaking people with probable PSP-Richardson syndrome for up to 12 months. Speech features were associated with clinical outcomes and changed over time. Within the study, machine learning models estimated concurrent and three-month clinical scores; broader predictive use requires further validation.
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Verbal fluency
In a preliminary, unpublished analysis of 30 participants assessed quarterly for one year, automated categorical fluency declined by an estimated 2.47 words per year, while MoCA scores showed no statistically significant change. This finding supports further study of fluency as a longitudinal measure.
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Physical activity and ambulation
In a preliminary, unpublished analysis from a study enrolling 44 people with probable PSP, PAMSys recorded activity for one week after quarterly visits over up to 12 months. Researchers examined change in activity and ambulation alongside PSP-QoL and CBFS scores. Preliminary findings support further evaluation of these measures against patient-reported function.
FDA qualification pathway for our digital measures in PSP
The FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) program provides a pathway for evaluating novel drug development tools. PAMSys has been accepted into the program for measuring ambulation in PSP clinical trials. The Letter of Intent for BioDigit Speech measures in PSP has been accepted for review.
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Wearable ambulation metrics
FDA has accepted PAMSys into the FDA ISTAND program as a drug development tool for measuring ambulation in progressive supranuclear palsy (PSP) clinical trials. PAMSys-derived ambulation measures support longitudinal assessment of walking during daily life.
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Automated speech function measures
The Letter of Intent proposes BioDigit Speech measures for native English-speaking adults with PSP. Standardized speech tasks assess articulatory precision, timing and fluency, voice quality, and prosody. The proposed tool has been accepted for review under the FDA ISTAND program.
A $3M NIH award supports digital measures in the PSP Trial Platform
A $3 million NIH award supports integrating BioSensics digital health technologies into the Progressive Supranuclear Palsy Trial Platform (PTP). The platform evaluates multiple candidate therapies under a shared protocol, with approximately 50 participating sites planned across North America.
Our clinical studies in PSP
Our observational studies combine digital assessments with wearable recordings. The cards show planned enrollment across each registered study. PSP2 and PSP3 statuses reflect January and June 2026 registry updates, respectively; follow the registry links for current details. The PSP3 protocol includes PSP and Lewy body conditions.
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Recruiting
BioDigit PSP
- ClinicalTrials.gov
- NCT04753320 (opens in a new tab)
- Planned total enrollment
- 85
- PSP follow-up
- 12 months
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Completed
BioDigit PSP2
- ClinicalTrials.gov
- NCT05956834 (opens in a new tab)
- Enrollment
- 49
- Participant follow-up
- 12 months
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Not yet recruiting
BioDigit PSP3
- ClinicalTrials.gov
- NCT07240805 (opens in a new tab)
- Planned total enrollment
- 160 (80 with PSP)
- Participant follow-up
- 12 months
Our research partners
Our PSP research brings together academic medical centers and patient advocacy organizations.
- Association for Frontotemporal Degeneration
- CurePSP
- Johns Hopkins University
- Massachusetts General Hospital
- University of California San Diego
- University of California San Francisco
- University of Hawaii
- University of Miami
- Vanderbilt University Medical Center
Selected publications and presentations
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Frontiers in Neuroscience, 2026
Analytical Validation of Digital Measure of Intelligibility in Progressive Supranuclear Palsy (opens in a new tab)
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Scientific Reports, 2026
Longitudinal Digital Speech Assessment in Progressive Supranuclear Palsy (opens in a new tab)
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Neurology, 2025 · Conference abstract
Longitudinal Remote Monitoring of Physical Activity and Falls in Progressive Supranuclear Palsy (opens in a new tab)
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Neurology, 2024 · Conference abstract
Remote Monitoring of Motor, Speech, and Cognitive Function in Progressive Supranuclear Palsy (opens in a new tab)
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MDA Conference, 2024 · Abstract
Using Speech Biomarkers to Identify and Track Neuromuscular and Neurodegenerative Disorders (opens in a new tab)
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MDS Congress, 2024 · Abstract
Remote Digital Longitudinal Assessment of Speech, Fluency and Cognitive Function in Progressive Supranuclear Palsy (opens in a new tab)
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BMC Neurology, 2023
Remote at-home wearable-based gait assessments in Progressive Supranuclear Palsy compared to Parkinson's Disease (opens in a new tab)
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Parkinsonism & Related Disorders, 2023
Utilizing speech analysis to differentiate progressive supranuclear palsy from Parkinson's disease (opens in a new tab)
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Neurology, 2023 · Conference abstract
Longitudinal study of Progressive Supranuclear Palsy (PSP) using remote at-home multi-modal digital assessments and wearable devices (opens in a new tab)
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MDS Congress, 2023 · Abstract
Remote monitoring of physical activity in Progressive Supranuclear Palsy (PSP) using wearable sensors (opens in a new tab)
Advance PSP research with digital measures
Explore collaboration in PSP research. Talk with our team about study design, research data access, and the use of digital measures in clinical trials.