Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04753320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2021-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Monitoring in Progressive Supranuclear Palsy (PSP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D012791', 'term': 'Shy-Drager Syndrome'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019578', 'term': 'Multiple System Atrophy'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2021-02-06', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary feasibility outcome', 'timeFrame': '12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Timed Up and Go (TUG)', 'timeFrame': '12 months', 'description': 'The Timed Up and Go and other timed gait and balance tests will be performed while wearing LegSys sensors'}, {'measure': 'PSPRS', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'MoCA', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Cortical Basal ganglia Functional Scale (CBFS)', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'PSP-QoL', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Progressive Supranuclear Palsy', 'Parkinson Disease', 'MSA - Multiple System Atrophy']}, 'referencesModule': {'references': [{'pmid': '27341134', 'type': 'BACKGROUND', '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.'}, {'pmid': '29733529', 'type': 'BACKGROUND', '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.'}, {'pmid': '27125836', 'type': 'BACKGROUND', '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."}, {'pmid': '38082255', 'type': 'DERIVED', 'citation': "Sharma M, Mishra RK, Hall AJ, Casado J, Cole R, Nunes AS, Barchard G, Vaziri A, Pantelyat A, Wills AM. Remote at-home wearable-based gait assessments in Progressive Supranuclear Palsy compared to Parkinson's Disease. BMC Neurol. 2023 Dec 11;23(1):434. doi: 10.1186/s12883-023-03466-2."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nSecondary objectives are to measure PSP progression using sensor-derived motor and tablet-derived speech and cognitive measures.\n\nIn 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* Male or female, aged 18 to 89 years, inclusive.\n* Fluent in reading and speaking English.\n* Capable of providing informed consent based on the investigator's judgment.\n* Able to comply with the protocol based on the investigator's judgment.\n* Able to walk 10 feet unassisted.\n* With access to a caregiver who is able to assist with all study-related procedures.\n\nExclusion Criteria:\n\n* Any neurological, medical, or psychiatric condition that would preclude participation in study activities based on the investigator's judgment.\n* A history of frequent falls defined as more than 5 falls/month or requirement of a walker to ambulate safely."}, 'identificationModule': {'nctId': 'NCT04753320', 'briefTitle': 'Remote Monitoring in Progressive Supranuclear Palsy (PSP)', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': "Remote Monitoring in Progressive Supranuclear Palsy, an Alzheimer's Disease Related Dementia", 'orgStudyIdInfo': {'id': 'Not yet available'}}, 'contactsLocationsModule': {'locations': [{'zip': '21093', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anne-Marie A Wills, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, CurePSP Center of Care', 'investigatorFullName': 'Anne-Marie Alexandra Wills, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}