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Rapid dEvice Testing pROtocol for Parkinson's Disease (RETRO-PD)

H

HealthMode

Status

Completed

Conditions

Healthy
Parkinson Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT04675853
HM041001

Details and patient eligibility

About

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 an 8-week monitoring period including 4 virtual visits where participants will use a combination of digital devices (Emerald touchless sensor system with associated ankle accelerometer, iPhone, Apple Watch, iPad, Fitbit Aria, FitBit Versa, Withings Blood Pressure Monitor Connect, and/or Withings Sleep Mat) during their daily lives.

Enrollment

12 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

12 participants in 2 patient groups

Participants with PD
Care Partners of PD participants

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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