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

Boston Medical Center (BMC)

Status: Withdrawn

Conditions: Parkinson Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05219019

H-41349

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

0 participants in 1 patient group

PD patients who have elected DBS

Description:

Ten individuals with moderate to advanced Parkinson's disease who have elected to undergo deep brain stimulation (DBS) of the subthalamic nucleus (STN) or internal globus pallidus (GPi) as standard of care for management of Parkinson's disease tremor and/or motor complications