[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04753320":3,"trial-entities:NCT04753320":126,"trial-summary:NCT04753320":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":35,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":67,"locations":70,"central_contacts":105,"overall_officials":108,"references":110,"see_also_links":125},"NCT04753320","Not yet available","Remote Monitoring in Progressive Supranuclear Palsy (PSP)","Remote Monitoring in Progressive Supranuclear Palsy, an Alzheimer's Disease Related Dementia","NOT_YET_RECRUITING","2028-12","2026-07","2026-07-29","2026-09-01","Massachusetts General Hospital","OTHER",false,"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.","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).",[19,20,21],"Progressive Supranuclear Palsy","Parkinson Disease","MSA - Multiple System Atrophy",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},85,"ESTIMATED",[],[31],{"measure":32,"description":33,"timeFrame":34},"Primary feasibility outcome","Compliance will be calculated as the number of participants who wear their PAMSys pendant sensors at least 16 hours\u002Fday 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",[36,39,42,45,48],{"measure":37,"description":38,"timeFrame":34},"Timed Up and Go (TUG)","The Timed Up and Go and other timed gait and balance tests will be performed while wearing LegSys sensors",{"measure":40,"description":41,"timeFrame":34},"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.",{"measure":43,"description":44,"timeFrame":34},"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.",{"measure":46,"description":47,"timeFrame":34},"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.",{"measure":49,"description":50,"timeFrame":34},"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.","ALL","18 Years","89 Years",{"inclusion":55,"exclusion":63,"raw_text":66},[56,57,58,59,60,61,62],"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.",[64,65],"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\u002Fmonth or requirement of a walker to ambulate safely.","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\u002Fmonth or requirement of a walker to ambulate safely.",[68,69],"ADULT","OLDER_ADULT",[71,86],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":83},"Johns Hopkins","Baltimore","Maryland","21093","United States",[78],{"name":79,"role":80,"phone":81,"email":82},"AJ Hall","CONTACT","410-616-2825","AtypicalPark@jh.edu",{"lat":84,"lon":85},39.29038,-76.61219,{"facility":13,"city":87,"state":88,"zip":89,"country":76,"contacts":90,"geoPoint":102},"Boston","Massachusetts","02114",[91,95,99],{"name":92,"role":80,"phone":93,"email":94},"Yvonne Kim, BS","617-643-2400","ykim118@mgh.harvard.edu",{"name":96,"role":80,"phone":97,"email":98},"Jesse Wang, BA","617-643-2643","jewang@mgh.harvard.edu",{"name":100,"role":101},"Anne-Marie A Wills, MD MPH","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},42.35843,-71.05977,[106,107],{"name":92,"role":80,"phone":93,"email":94},{"name":96,"role":80,"phone":93,"email":98},[109],{"name":100,"affiliation":13,"role":101},[111,115,118,121],{"pmid":112,"type":113,"citation":114},"27341134","BACKGROUND","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\u002FJHD-160197.",{"pmid":116,"type":113,"citation":117},"29733529","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\u002Fbrb3.977. Epub 2018 May 7.",{"pmid":119,"type":113,"citation":120},"27125836","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\u002Fmds.26642. Epub 2016 Apr 29.",{"pmid":122,"type":123,"citation":124},"38082255","DERIVED","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\u002Fs12883-023-03466-2.",[],{"nct_id":4,"conditions":127,"biomarkers":129},[128,20,19],"Multiple System Atrophy",[],{"nct_id":4,"found":131,"summary":132,"prompt_version":142},true,{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is an observational study, meaning it watches and records information without giving any specific treatments. It plans to include about 85 participants.","completed","Remote Monitoring for Progressive Supranuclear Palsy (PSP)","This study is looking at how well wearable sensors and digital health tools can track falls and changes in movement, speech, and thinking abilities in people with Progressive Supranuclear Palsy (PSP), Parkinson's disease, or Multiple System Atrophy (MSA). It's also open to healthy volunteers. The study aims to see if these remote monitoring tools are practical to use over about one year. You would be using a wearable sensor and a study-provided tablet to complete assessments from home, with some virtual meetings with the study team. The study plans to enroll about 85 participants aged 18 to 89 who can read and speak English.","Participants with PSP and MSA will be monitored for approximately one year. Parkinson's and healthy control participants will be seen once at baseline only.",104,"You would wear a sensor daily and complete monthly supervised remote assessments, including gait and balance tasks, and cognitive tests on a tablet. More extensive virtual testing would occur every three months.","Not stated in the trial record.",[],"v2"]