Objective Quality of Life Detection Validation
10. august 2020 oppdatert av: Great Lakes NeuroTechnologies Inc.
DiSCERN Phase I - Objective Quality of Life Detection Validation
The purpose of this research study is to:
- Collect data to use in the development of a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) such as deep brain stimulation (DBS) and drug pumps.
- Determine the level to which specific activities reflect with quality of life in individuals with PD.
- Obtain feedback from individuals with Parkinson's disease and clinicians on the usability of the system.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The investigators aim to develop a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) and identify when AT recipients are in need of a therapy adjustment.
This system will integrate ambulatory PD monitoring with context aware activity detection as the daily activities a patient performs are often the best predictors of quality of life (QoL).
In this study the Kinesia 360 system will collect motion data to measure tremor, bradykinesia (slow movement), and dyskinesia (involuntary movements) from individuals with PD to track their symptoms throughout the day.
A smartphone will collect information on subject location and activity using the GPS, accelerometers, and microphone within the phone to find correlations between activity and patient wellness.
This data will be used to improve detection over time and predict whether patients are candidates for advanced therapies.
Studietype
Observasjonsmessig
Registrering (Faktiske)
10
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forente stater, 44131
- Great Lakes NeuroTechnologies
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The population is people with Parkinson's Disease in the Northeast Ohio region who have expressed interest in participating in clinical trials
Beskrivelse
Inclusion Criteria:
- Able to provide informed consent
- Diagnosed with PD
- Hoehn and Yahr scale I-III
- Able to travel to Great Lakes NeuroTechnologies
- Ambulatory and capable of using the Kinesia 360 system
- Able to understand and follow instructions regarding using the device
Exclusion Criteria:
Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Parkinson's Disease
Parkinson's Disease patients
|
Data will be recorded from the Kinesia 360 system and smartphone sensors using the AWARE Framework.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Kinesia Symptom Scores during Daily Wear
Tidsramme: Continuous during wear over four days
|
Kinesia 360 scoring of Parkinson's Disease motor symptoms (tremor, slowness, dyskinesia, gait): The Kinesia 360 system translates recorded motion into 0-4 scores that correlate to rating scales used by clinicians (lower scores are signifiers of better outcomes and higher scores signify worse outcomes).
A separate 0-4 score is generated for tremor, slowness, and dyskinesia, and gait is tracked for step count and percent of day walking.
|
Continuous during wear over four days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
User environment audio activity
Tidsramme: Continuous during wear over four days
|
Using the AWARE Framework, the microphone in the smartphone will be used to measure ambient noise and detect conversation during wear.
The output will be detection of conversation and ambient noise level for each recorded timepoint.
The time involved in conversation and around active ambient noise will be compared to the symptom scores to measure user involvement in active environments as an impact on Parkinson's disease symptoms.
|
Continuous during wear over four days
|
|
Patient physical activity
Tidsramme: Continuous during wear over four days
|
Using the AWARE Framework, accelerometers in the smartphone will be used to determine the activity of the user.
The accelerometers will detect if the phone is being carried (using orientation of gravity) and predict most likely physical activity (using pre-existing activity recognition algorithms).
The output will be predicted user activity for each timepoint recorded which will be correlated to Kinesia symptom scores.
|
Continuous during wear over four days
|
|
Patient locations and travel
Tidsramme: Continuous during wear over four days
|
Using the AWARE Framework, Global Positioning System (GPS) tracking in the smartphone will be used to determine the locations and activity of the user.
The GPS sensor will be used to track changes in location and determine when an user is at home (primary location), in a secondary location, or in active motion (car, bike, or walking).
The outcome will be time spent in each location, percent of day at each location, and time and speed travelling between locations.
These outcomes will be correlated to the Kinesia symptom scores and detected physical activity.
|
Continuous during wear over four days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dustin Heldman, PhD, Director of research
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. september 2019
Primær fullføring (Faktiske)
30. juni 2020
Studiet fullført (Faktiske)
30. juni 2020
Datoer for studieregistrering
Først innsendt
26. september 2019
Først innsendt som oppfylte QC-kriteriene
8. oktober 2019
Først lagt ut (Faktiske)
10. oktober 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DiSCERN1
- 1R44MD013767-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .