Parkinson Disease Clinical Trial
— FoRMA-DBSOfficial title:
Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS)
NCT number | NCT05219019 |
Other study ID # | H-41349 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | June 2022 |
Est. completion date | February 2023 |
Verified date | July 2022 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center |
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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