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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD patients who have elected DBS<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of remotely assessing gait speed during DBS therapy initiation | A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess gait speed. | 20 weeks | 
| Feasibility of remotely assessing functional mobility during DBS therapy initiation | A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess functional mobility. | 20 weeks | 
| Feasibility of remotely assessing balance during DBS therapy initiation | A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess balance. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility assessment: 4 meter walk | Gait speed as performed during the 4-meter walk: Measured as time taken to walk 4 meters in seconds. | days -42, -28, 21, 28, 42, 56, 70, and 84 | 
| Mobility assessment: Timed up and go (TUG) | The TUG assesses mobility, balance, walking ability and fall risk in older adults and has been validated showing good agreement between in-person and telehealth and raters. On the command, go the patient rises from the chair, walks 3 meters at a comfortable safe pace, turns and walks back to the chair and sits down. Measured as time taken to complete task in seconds. | days -42, -28, 21, 28, 42, 56, 70, and 84 | 
| Mobility assessment: 5 times sit to stand | This is a timed task that requires the participant to stand from a seated position five times in a row. Measured as time taken to complete task in seconds. | days -42, -28, 21, 28, 42, 56, 70, and 84 | 
| Mobility assessment: 360 degree turns | The 360 degree turn test is a measure of dynamic balance in which the participant turns in a complete circle. Measured as time taken to complete task in seconds. | days -42, -28, 21, 28, 42, 56, 70, and 84 | 
| Mobility assessment: Activity-specific balance confidence (ABC) scale | Self-reported confidence in performing 16 activities without losing balance. Participants rate using an 11-point likert-type scale, from 0% (no confidence) to 100% (completely confident) with 10% increments. A total score will be calculated as the mean of the items. | days -42, -28, 21, 28, 42, 56, 70, and 84 | 
| Mobility assessment: Single-leg stance | Amount of time participant is able to stand on one leg (performed for each leg), measured in seconds. | Day -28, 21, 42, 56, 70 | 
| Movement disorders | The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV The Movement Disorder Society's Unified Parkinson's Disease Rating Scales (MDS-UPDRS) consists of 65 items across four domains: non-motor experiences, motor experiences, a motor examination, and motor complications, rated from 0 (normal) to 4 (severe). Subscales and a total score are calculated by adding items. A higher score is a worse outcome and indicates more severe symptoms of Parkinson's disease. | day -42 and day 84 | 
| Quality of Life in PD | The Parkinson's Disease Questionnaire (PDQ-39) will be used to assess living difficulties across 8 dimensions of daily living including mobility subscores. The PDQ-39 assesses life concerns of individuals with PD. It is composed of a summary index and eight domain scores-mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each item is rated on a 0 (never) to 4 (always) scale. A higher score indicates a higher self-perceived frequency of quality of life and health problems in the past month that are due to the disease, with each domain normed to a scale on which 0 indicating never a problem and 100 always a problem. The summary index is the average of the normed domain scores. A higher score is a worse outcome for quality of life. | day -42 and day 84 | 
| Change in 3-day step count before DBS | Step count will be measured continuously by a StepWatch4 over a 3 day period. | day -42, day 84 | 
| Change in amount of time spent with tremor and dyskinesia | The amount of time spent with tremor and dyskinesia will be measured with the Apple watch. | baseline, day 84 | 
| Patient global impression of change | The Patient Global Impression - Improvement scale (CGI-I) is a 7 point scale, from 1 (normal) through to 7 (amongst the most severely ill), that requires the patient to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the study. Higher scores reflect more severe illness. | baseline, day 28, 42, 56, 70 and 84 | 
| Clinician global impression of change | The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale, from 1 (normal) through to 7 (amongst the most severely ill), that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the study. Higher scores reflect more severe illness. | baseline, day 28, 42, 56, 70 and 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internal globus pallidus (GPi), Deep brain stimulation (DBS), Remote monitoring, Subthalamic nucleus (STN), Patient Global Impression of Change (PGIC), Activities Balance Confidence Scale (ABC), Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)