Remote Monitoring in Progressive Supranuclear Palsy (PSP)

Progressive Supranuclear Palsy Clinical Trial

Official title:

Remote Monitoring in Progressive Supranuclear Palsy, an Alzheimer's Disease Related Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753320
• Other study ID #: Not yet available
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: Mansi Sharma, BS
• Phone: 617-643-2400
• Email: msharma13[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, 40-50 individuals with possible or probable PSP will be enrolled at 4-5 sites in the U.S. and followed for one year. During the monitoring period (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). 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDS criteria[12].
• 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.

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Timed Up and Go (TUG)	The Timed Up and Go and other timed gait and balance tests will be performed while wearing LegSys sensors	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	PSP-QoL	The PSP Quality of Life scale will be performed every 3 months remotely. The PSP-QoL is a 45 item scale, with a possible scale of 0-100 with lower scores less affected.	12 months