Health TrialsbyHealthPanel

Remote Monitoring in Progressive Supranuclear Palsy (PSP)

ConditionsProgressive Supranuclear PalsyParkinson DiseaseMSA - Multiple System Atrophy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorMassachusetts General Hospital

About this trial

This is a single-arm, longitudinal, observational study on the use of wearable sensors and digital health technology to measure fall frequency and motor, speech, and cognitive function in patients with PSP over the course of approximately one year. Participants will perform supervised remote assessments monthly and in-person assessments approximately every 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDS criteria, clinical diagnosis of at least probable PD as defined by the 2015 MDS criteria, or clinical diagnosis of at least probable MSA as defined by the 2022 MDS criteria, or healthy controls.

Male or female, aged 18 to 89 years, inclusive.

Fluent in reading and speaking English.

Capable of providing informed consent based on the investigator's judgment.

Disqualifiers

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/month or requirement of a walker to ambulate safely.

Trial population

All participants with clinical diagnosis of possible or probable PSP, probable PD, or possible or probable MSA are eligible to participate in this study. Participants must be able to ambulate unassisted for 10 feet in order to perform gait and balance tests.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Primary feasibility outcome

Compliance will be calculated as the number of participants who wear their PAMSys pendant sensors at least 16 hours/day for at least 180 days and complete at least 80% of their scheduled monthly sensor and tablet derived motor, speech, and cognitive assessments through their 6 month visit.

Time frame
12 months

Secondary outcomes

1

Timed Up and Go (TUG)

The Timed Up and Go and other timed gait and balance tests will be performed while wearing LegSys sensors

Time frame
12 months
2

PSPRS

The Progressive Supranuclear Palsy Rating Scale will be administered remotely or 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.

Time frame
12 months
3

MoCA

The Montreal Cognitive Assessment and other cognitive tests will be performed remotely every 3 months. The MoCA is has a total of 30 points and greater than 26 is considered normal.

Time frame
12 months
4

Cortical Basal ganglia Functional Scale (CBFS)

The Cortical Basal ganglia Functional Scale (CBFS) will be performed every 3 months remotely. The CBFS is a 31 item scale, with a total of 124 possible points, where a lower score is less affected.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Johns Hopkins University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: