Status:
WITHDRAWN
Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS)
Lead Sponsor:
Boston Medical Center
Conditions:
Parkinson Disease
Eligibility:
All Genders
35-80 years
Brief Summary
This is an observational pilot study to assess the feasibility of remote functional assessments of gait, balance, and functional mobility via a telemedicine platform enabled via the Abbott Infinity de...
Detailed Description
This is a single-center, non-randomized pilot observational study to explore the feasibility and tolerability of remotely assessing gait speed, functional mobility and balance measures in patients wit...
Eligibility Criteria
Inclusion
- Patients with with Parkinson's disease, as confirmed by the treating investigator, providing written consent to the clinical study
- Participants have been determined by the treating investigator as candidates for DBS
- Participants who have opted to have DBS with the remote-programming capable platform
- Have internet connection at home or wherever participants will be receiving care remotely and be able to participate in telemedicine visits and remote programming
Exclusion
- Has already had prior surgical lesioning or deep brain stimulation therapy
- Meets criteria for Parkinson's disease dementia in the opinion of the treating investigator
- Does not have capacity for consent as judged by the treating investigator
- Scores less than 24 on the Montreal Cognitive Assessment (MoCA) at standard of care DBS screening, indicating, at least, mild cognitive impairment
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05219019
Start Date
June 1 2022
End Date
February 1 2023
Last Update
July 13 2022
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