Status:
COMPLETED
Rapid dEvice Testing pROtocol for Parkinson's Disease
Lead Sponsor:
HealthMode Inc.
Conditions:
Parkinson Disease
Healthy
Eligibility:
All Genders
30+ years
Brief Summary
This is an 8 week observational study to evaluate the feasibility of using remote monitoring technologies in future studies of PD. The study will 2 clinical evaluations (one initial, one final), and a...
Eligibility Criteria
Inclusion
- Participants with PD
- At least 30 years of age
- Clinical diagnosis of PD by a neurologist or other movement disorder specialist as reported by the participant, with current motor symptoms
- Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)
- Have a BMI of 33 or below calculated by participant reported height and weight at the time of screening
- Have a care partner who meets the study's inclusion criteria
- Able to read, understand, and provide written informed consent in English
- Able, either alone or with a care partner, to operate digital devices
- Have reliable wifi in their home and the ability to connect new devices to their home wifi
- Care partners
- At least 18 years of age
- Able to read, understand, and provide written informed consent in English
- Able to operate digital devices
- Care partner for the participant with PD enrolled in the study
- Lives with the participant with PD enrolled in the study
- Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)
- Willing to exclude pet from the participant's bedroom at night for the duration of the study
Exclusion
- Participants with PD
- Any non-PD forms of Parkinsonism
- Active psychiatric disorders that affect the ability to complete study tasks
- Any other medical condition that is the primary cause of the present movement disorder
- Cognitive dysfunction (score \> 7 on the Six-Item Cognitive Impairment Test)
- Considered by the investigator to be an unsuitable participant
- Live in a household with more than three people
- Unwilling to exclude pet from their bedroom at night for the duration of the study
- Care partners
- Cognitive dysfunction (score \> 7 on the Six-Item Cognitive Impairment Test)
- Considered by the investigator to be an unsuitable participant
Key Trial Info
Start Date :
November 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 25 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04675853
Start Date
November 25 2020
End Date
November 25 2021
Last Update
July 22 2022
Active Locations (1)
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1
Mobile Clinical Research Site
New York, New York, United States, 10001