NCT05219019

Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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 devices. The clinical care of the participant will not be changed based on the remote functional assessments.

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 with Parkinson's disease experiencing medication-refractory tremor, motor complications and/or dyskinesias undergoing initiation of deep brain stimulation therapy. This study explores the feasibility of remotely performing and collecting functional assessments of gait, balance and mobility in the setting of programming deep brain stimulation (DBS). Ten participants who are deemed surgical candidates for receiving DBS for Parkinson's disease under standard of clinical care processes (neuropsychological testing, neurology consultation and neurosurgery consultation) and have opted for the Abbott DBS system will be enrolled in the study and undergo the pre-surgical and post-surgical visits. A pre-operative in-clinic visit will take place approximately 28 days (day -42) prior to surgical DBS electrode lead implantation. An at-home assessment will take place within 14 days (day -28) of this baseline visit, still prior to surgical DBS electrode lead implantation. Participants will receive care as usual including their first post-operative clinic visit for initial programming (day 28), just like standard of care for DBS patients.

Conditions

• Parkinson Disease

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-02-01
• Last updated: 2022-07-13