Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change from baseline in the Mini-Balance Evaluation Systems Test |
a measure of dynamic balance, functional mobility, and gait. This measure will be evaluated as a safety outcome to assess whether device therapy negatively impacts balance or gait for participants with Parkinson's disease (day 197 score) |
8 months |
|
| Other |
Change from baseline in the Montreal Cognitive Assessment |
a screening instrument used to facilitate the assessment of cognitive impairment. |
8 months |
|
| Other |
Change from baseline in the Oral Symbol Digit Modality Test |
a brief and commonly used tests to evaluate processing speed |
8 months |
|
| Other |
Change from baseline in the Parkinson's Disease Sleep Scale |
an assessment to quantify nocturnal sleep issues in Parkinson's disease |
8 months |
|
| Other |
Change from baseline in Epworth Sleepiness Scale |
a brief measure that is commonly used to assess daytime sleepiness |
8 months |
|
| Other |
Change from baseline in the Parkinson Anxiety Scale |
a brief questionnaire to detect anxiety severity in Parkinson's disease |
8 months |
|
| Other |
Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale |
a measure of an individual's level of fatigue during their usual daily activities over the past week |
8 months |
|
| Other |
Change from baseline in the Geriatric Depression Scale-15 |
a short questionnaire for assessing depression in older adults |
8 months |
|
| Other |
Change from baseline in the MDS-NMS Non-Motor Fluctuations |
a rater completed assessment evaluating fluctuations of non-motor symptoms in Parkinson's disease |
8 months |
|
| Other |
Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV |
an assessment of complications of anti-Parkinsonian therapies |
8 months |
|
| Other |
Change from baseline in a Non-Motor Symptom focused Clinical Global Impression-Improvement |
clinician assessment the extent of clinically meaningful change that has occurred as it relates to the patient's non-motor symptoms |
8 months |
|
| Other |
Change from baseline in the Zarit Burden Interview |
measure of caregiving burden completed by caregivers |
8 months |
|
| Other |
Change from baseline in the Patient Reported Outcome - Parkinson's Disease |
a self-rating tool to assess symptom severity in Parkinson's disease |
8 months |
|
| Other |
Change from baseline in The Modified Schwab and England Activities of Daily Living Scale |
a clinical outcome assessment of an individual's ability to function independently in activities of daily living |
8 months |
|
| Other |
Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test |
smart phone application assessment that provides indication of risk of falls in adults |
8 months |
|
| Other |
Change from baseline in EncephaLogTM finger tapping test |
smart phone application providing a quantitative measure of bradykinesia |
8 months |
|
| Other |
Change from baseline in EncephaLogTM 10m Timed Up and Go (10m TUG) |
smart phone application that measures gait and that provides indication of risk of falls in adults |
8 months |
|
| Other |
Change from baseline in Unified Parkinson's disease Rating Scale Part I (UPDRS I) |
a measure of mentation, behavior, and mood in Parkinson's disease |
8 months |
|
| Other |
Change from baseline in Hoehn & Yahr (H&Y) |
staging tool describing the level of disability in Parkinson's disease |
8 months |
|
| Other |
Change from baseline in Patient Global Impression of Improvement |
a patient determined scale to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention |
8 months |
|
| Primary |
Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score |
The MDS- NMS is 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. Scores range between 0-832, with the higher score indicating greater non-motor symptom burden. (day 197 score) |
8 months |
|
| Secondary |
Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II |
The MDS- UPDRS Part II is a 13- item patient-reported assessment of activities of motor aspects of experiences of daily living. Scores range between 0-52, with the higher score indicating greater impairment to activities of daily living. (day 197 score) |
8 months |
|
| Secondary |
Change from baseline in the Clinical Global Impression - Improvement (CGI-I) |
The CGI-I is a clinician assessment the extent of clinically meaningful change that has occurred in the patient's illness at day 113 relative to a baseline state (assessed at day 29). Changes in all aspects of Parkinson's disease (e.g., motor symptoms, non-motor symptoms and complications of anti-Parkinsonian medications) are considered. |
8 months |
|
| Secondary |
Change from baseline in the MDS-UPDRS Part III |
The MDS-UPDRS Part III is a 33-item assessment of motor function evaluated by a trained blinded rater. Scores range between 0-132 with higher scores indicating more sever motor symptoms. (day 197 score) |
8 months |
|
| Secondary |
Change from baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI) |
The PDQ-39 SI is a 39-item patient-reported quality of life measure that assesses how often people living with PD are affected across 8 dimensions of daily living. Scores range from 0-100, with the higher scores indicating worse perception of quality of life. (day 197 score) |
8 months |
|
