Clinical trial NCT05219019: Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS)
Official title: Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson Disease
Keywords: Deep brain stimulation (DBS)
Remote monitoring
Subthalamic nucleus (STN)
Internal globus pallidus (GPi)
Patient Global Impression of Change (PGIC)
Activities Balance Confidence Scale (ABC)
Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of remotely assessing gait speed during DBS therapy initiation
timeFrame: 20 weeks
measure: Feasibility of remotely assessing functional mobility during DBS therapy initiation
timeFrame: 20 weeks
measure: Feasibility of remotely assessing balance during DBS therapy initiation
timeFrame: 20 weeks
Secondary outcomes:
measure: Mobility assessment: 4 meter walk
timeFrame: days -42, -28, 21, 28, 42, 56, 70, and 84
measure: Mobility assessment: Timed up and go (TUG)
timeFrame: days -42, -28, 21, 28, 42, 56, 70, and 84
measure: Mobility assessment: 5 times sit to stand
timeFrame: days -42, -28, 21, 28, 42, 56, 70, and 84
measure: Mobility assessment: 360 degree turns
timeFrame: days -42, -28, 21, 28, 42, 56, 70, and 84
measure: Mobility assessment: Activity-specific balance confidence (ABC) scale
timeFrame: days -42, -28, 21, 28, 42, 56, 70, and 84
measure: Mobility assessment: Single-leg stance
timeFrame: Day -28, 21, 42, 56, 70
measure: Movement disorders
timeFrame: day -42 and day 84
measure: Quality of Life in PD
timeFrame: day -42 and day 84
measure: Change in 3-day step count before DBS
timeFrame: day -42, day 84
measure: Change in amount of time spent with tremor and dyskinesia
timeFrame: baseline, day 84
measure: Patient global impression of change
timeFrame: baseline, day 28, 42, 56, 70 and 84
measure: Clinician global impression of change
timeFrame: baseline, day 28, 42, 56, 70 and 84
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Ludy Shih, MD MMSc
role: PRINCIPAL_INVESTIGATOR
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