Clinical trial NCT04753320: Remote Monitoring in Progressive Supranuclear Palsy (PSP)
Official title: Remote Monitoring in Progressive Supranuclear Palsy, an Alzheimer's Disease Related Dementia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Progressive Supranuclear Palsy
Parkinson Disease
MSA - Multiple System Atrophy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2021-02-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: The primary objective of this study is to determine the feasibility of using wearable sensors and digital health technology to remotely monitor patients with possible or probable PSP.

Secondary objectives are to measure PSP progression using sensor-derived motor and tablet-derived speech and cognitive measures.

In brief, approximately 85 individuals with possible or probable PSP, probable Parkinson's disease, possible or probable Multiple System Atrophy, and healthy controls, will be enrolled at 4-5 sites in the U.S. and followed for one year. During the monitoring period for PSP and MSA participants (1 year), a wearable pendant sensor (PAMSys, BioSensics) will be used to monitor falls and physical activity (step counts) of all participants during activities of daily living (ADL). Parkinson's and healthy control participants will be seen once at baseline only. On a monthly basis, participants will have televideo conferences with the sites to perform supervised gait and balance tasks while wearing 3 LEGSys (BioSensics) sensors. Using a study-supplied tablet, participants will also perform cognitive tests including fluency, color trails and go-no-go tapping tests. Participants will undergo more extensive testing every 3 months including the PSPRS, MoCA, quality of life questionnaires and functional rating scales which will be performed remotely (virtually). Approximately 6 months participants will undergo an in-person PSPRS (to coincide with their clinic appointments).

Eligibility criteria: Inclusion Criteria:

* 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.
* Able to comply with the protocol based on the investigator's judgment.
* Able to walk 10 feet unassisted.
* With access to a caregiver who is able to assist with all study-related procedures.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary feasibility outcome
timeFrame: 12 months
Secondary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: 12 months
measure: PSPRS
timeFrame: 12 months
measure: MoCA
timeFrame: 12 months
measure: Cortical Basal ganglia Functional Scale (CBFS)
timeFrame: 12 months
measure: PSP-QoL
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne-Marie A Wills, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrzejewski KL, Dowling AV, Stamler D, Felong TJ, Harris DA, Wong C, Cai H, Reilmann R, Little MA, Gwin JT, Biglan KM, Dorsey ER. Wearable Sensors in Huntington Disease: A Pilot Study. J Huntingtons Dis. 2016 Jun 18;5(2):199-206. doi: 10.3233/JHD-160197.
citation: Raccagni C, Gassner H, Eschlboeck S, Boesch S, Krismer F, Seppi K, Poewe W, Eskofier BM, Winkler J, Wenning G, Klucken J. Sensor-based gait analysis in atypical parkinsonian disorders. Brain Behav. 2018 Jun;8(6):e00977. doi: 10.1002/brb3.977. Epub 2018 May 7.
citation: Espay AJ, Bonato P, Nahab FB, Maetzler W, Dean JM, Klucken J, Eskofier BM, Merola A, Horak F, Lang AE, Reilmann R, Giuffrida J, Nieuwboer A, Horne M, Little MA, Litvan I, Simuni T, Dorsey ER, Burack MA, Kubota K, Kamondi A, Godinho C, Daneault JF, Mitsi G, Krinke L, Hausdorff JM, Bloem BR, Papapetropoulos S; Movement Disorders Society Task Force on Technology. Technology in Parkinson's disease: Challenges and opportunities. Mov Disord. 2016 Sep;31(9):1272-82. doi: 10.1002/mds.26642. Epub 2016 Apr 29.