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Clinical assessments can only offer a snapshot of daily life with Parkinson's Disease, while wearable devices can offer immensely more information that can improve the understanding of this disease. With recent advancements in technology, investigators are now able to use watch-like devices to more effectively measure the symptoms of Parkinson's Disease outside of the doctor's office. The present study is designed to evaluate the usability, applicability, and interpretability of an electronic VA Patient Motor Diary (eON-OFF), MC10 BioStampRC actigraphy sensor, APDM actigraphy sensor and the GENEActiv Watch in persons with Parkinson's Disease. There is no placebo/control group.
The proposed study will be comprised of at least four sessions in the Spivack Center (Rm. X-140) on separate days (not counting recruitment, screening, or consent activities), each lasting approximately 1-2 hours. Subjects will commence a 1-week testing period during which they will wear the 3 actigraphy devices in their normal schedule and daily environment. On Days 2, 3, 4, and 5, subjects will use the eON-OFF motor diary application to select their current Parkinson state (e.g. "on", "off"). ON and OFF states are subjective measures identified by subjects, and are commonly used words in Parkinson's Disease treatment and research to describe symptom states. Symptom severity is directly linked to medication effectiveness. "On" is when the medication is working and symptoms are not severe or troublesome. "Off" is when medication has worn off, and symptom severity increases. Subjects will also use the eON-OFF motor diary application to verbally record symptomology every 30 minutes while awake. Subjects will complete paper VA Patient Motor Diaries to record ON and OFF states on Day 2, Day 3, and Day 4. Subjects will then complete the outlined set of activities during Phase I in a second phase to take place approximately one month later. All questionnaires, training and interviews will be administered one-on-one by a trained research assistant. All UPDRS' will be administered by a clinician. Ideally, subjects will be administered the study activities on the days listed above, but they are allowed a flexibility of +/- 4 days for scheduling appointments.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC10 BioStampRC | Device | Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices. | ||
| APDM actigraphy device | Device | Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices. | ||
| GENEActiv watch | Device | Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of eON-OFF mobile application ("eON-OFF app") in PD subjects. | Subjects will use the eON-OFF motor diary application to select their current Parkinson state (e.g. "on", "off"). Subjects will also use the eON-OFF motor diary application to verbally record symptomology every 30 minutes while awake. | 2 week long periods spaced a month apart |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence testing of the eON-OFF app on provisioned devices against established paper-based clinical assessment. | Subjects will complete paper VA Patient Motor Diaries to record ON and OFF states. ON and OFF states are subjective measures identified by subjects, and are commonly used words in Parkinson's Disease treatment and research to describe symptom states. | 2 week long periods spaced a month apart |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals diagnosed with Parkinson's disease.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C Thomas, PhD MBA | BU Anatomy and Neurology Dept, Evans Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evans Biomedical Research Center | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Evaluation of the usability and applicability of 3 wearable sensor systems in assessing clinical measures of PD. | Subjects will undergo two, 1-week testing periods during which they will wear the 3 actigraphy devices in their normal schedule and daily environment. | 2 week long periods spaced a month apart |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |