PSPNCT05956834
A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes
An observational study of PSP and CBD, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- PSP, CBD, Progressive Supranuclear Palsy
- What is being tested?
- PAMSys and LEGSys
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2023to 30 Dec 2027
- 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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study intends to enroll a diverse population of individuals representative of the general PSP population. There are no restrictions based upon race or ethnic origin. This study will recruit both male and female participants aged 40 years or older with a clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDS criteria.
Who may be able to join
- Clinical diagnosis of possible or probable PSP as defined by the 2017 MDS criteria
- Fluent in reading and speaking English and capable of providing informed consent based on the principal investigator's judgement
- Able to walk 10 feet unassisted at the time of initial enrollment
- Must have a caregiver or study partner who is willing and able to assist with all study-related procedures
Who cannot join
- Any neurological, medical, or psychiatric condition that would preclude participation in study activities based on the investigator's judgment.
- A history of frequent falls defined as more than 5 falls per month, or who require a walker to ambulate safely at baseline will not be eligible to participate in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21093
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months.
The secondary objective of this study is to develop a robust solution for multi-modal remote monitoring of motor symptoms and function in PSP that can be applied to other Frontotemporal lobar degeneration (FTLD) syndromes.
Read the detailed description
The goal of this project is to develop a robust multi-modal platform for remote monitoring of motor symptoms and cognitive function in FTLD syndromes using wearable sensors and mobile health technology to assess speech, motor, and cognitive functions. The solution will be validated in Progressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP individuals with PSP. Enrollment will take place over a period of 24 months, though each participant will only be followed for 12 months for data collection. The participants will consist of adult volunteers from two leading CurePSP Centers of Care located at the Atypical Parkinsonism Center at Johns Hopkins Hospital in Baltimore, MD and Massachusetts General Hospital (MGH) in Boston, MA.
- Conditions
- PSP, CBD, Progressive Supranuclear Palsy, FTD, Corticobasal Degeneration, Frontotemporal Dementia
- Being tested
- PAMSys, LEGSys
- Medical subject headings
- Supranuclear Palsy, Progressive, Corticobasal Degeneration, Frontotemporal Dementia, Frontotemporal Lobar Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAMSysDevice
Wearable accelerometer and gyroscope for measuring movement
LEGSysDevice
Wearable accelerometer and gyroscope for measuring movement
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility will be defined by the number of participants who complete the 12 month study and who wear their PAMSys pendant sensors at least 16 hours/day for at least 75% of the designated sensor days (7 days per month).
Measured: 12 months
Secondary outcomes (3)
PSPRS
The Progressive Supranuclear Palsy Rating Scale will be administered in-person every 3 months. The PSPRS is a 28 item scale with a total score of 0-100 where lower scores are less affected.
Measured: 12 months
Cortical Basal ganglia Functional Scale (CBFS)
The Cortical Basal ganglia Functional Scale (CBFS) will be performed every 3 months. The CBFS is a 31 item scale, with a total of 124 possible points, where a lower score is less affected.
Measured: 12 months
PSP Quality of Life scale (PSP QoL)
The PSP Quality of Life scale will be performed every 3 months. The PSP-QoL is a 45 item scale, with a possible scale of 0-100 with lower scores less affected.
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 posted21 Jul 2023
- Study start28 Jul 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSPStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, BioSensics
- Responsible party
- Principal investigator, Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956834
- Sponsor's protocol ID
- IRB00341607
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes
- ClinicalTrials.gov ID
- NCT05956834
- Acronym / sponsor ID
- IRB00341607
- Conditions
- PSP, CBD, Progressive Supranuclear Palsy, FTD, Corticobasal Degeneration, Frontotemporal Dementia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Johns Hopkins University, BioSensics
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 21 Jul 2023 (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 primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months.
The secondary objective of this study is to develop a robust solution for multi-modal remote monitoring of motor symptoms and function in PSP that can be applied to other Frontotemporal lobar degeneration (FTLD) syndromes.
Detailed description
The goal of this project is to develop a robust multi-modal platform for remote monitoring of motor symptoms and cognitive function in FTLD syndromes using wearable sensors and mobile health technology to assess speech, motor, and cognitive functions. The solution will be validated in Progressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP individuals with PSP. Enrollment will take place over a period of 24 months, though each participant will only be followed for 12 months for data collection. The participants will consist of adult volunteers from two leading CurePSP Centers of Care located at the Atypical Parkinsonism Center at Johns Hopkins Hospital in Baltimore, MD and Massachusetts General Hospital (MGH) in Boston, MA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study intends to enroll a diverse population of individuals representative of the general PSP population. There are no restrictions based upon race or ethnic origin. This study will recruit both male and female participants aged 40 years or older with a clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDS criteria.
Key inclusion criteria (4 listed)
- Clinical diagnosis of possible or probable PSP as defined by the 2017 MDS criteria
- Fluent in reading and speaking English and capable of providing informed consent based on the principal investigator's judgement
- Able to walk 10 feet unassisted at the time of initial enrollment
- Must have a caregiver or study partner who is willing and able to assist with all study-related procedures
Key exclusion criteria (2 listed)
- Any neurological, medical, or psychiatric condition that would preclude participation in study activities based on the investigator's judgment.
- A history of frequent falls defined as more than 5 falls per month, or who require a walker to ambulate safely at baseline will not be eligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAMSysWearable accelerometer and gyroscope for measuring movement | Device | – |
| LEGSysWearable accelerometer and gyroscope for measuring movement | Device | – |
Primary outcome
Feasibility
Time frame: 12 months
Feasibility will be defined by the number of participants who complete the 12 month study and who wear their PAMSys pendant sensors at least 16 hours/day for at least 75% of the designated sensor days (7 days per month).
3 secondary outcomes
PSPRS
Time frame: 12 months
Cortical Basal ganglia Functional Scale (CBFS)
Time frame: 12 months
PSP Quality of Life scale (PSP QoL)
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 21 Jan 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be available upon reasonable request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 PSP and CBD, run by Massachusetts General Hospital 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 12 months). 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 21 Jan 2026.