eOnOff - D1 Extension

NCT03247387 | Completed

• 1 other identifier: H-35364
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Wearable device; Patient monitor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Equivalence testing of the eON-OFF app on provisioned devices against established paper-based clinical assessment.

  2 week long periods spaced a month apart

• Evaluation of the usability and applicability of 3 wearable sensor systems in assessing clinical measures of PD.

  2 week long periods spaced a month apart

Interventions

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.

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with Parkinson's disease.

You may qualify if:

• Self-reported clinical diagnosis of Parkinson's disease consistent with the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
• Self-reported ability to recognize their "wearing off" symptoms and confirmation that they usually improve after their next dose of Parkinson's disease medication.
• Parkinson's disease Hoehn \& Yahr Stage less than or equal to III (assessed while the patient is "ON").
• Currently responding to L-Dopa therapy. On a stable dose of L-Dopa (or L-Dopa equivalent) of at least 300 mg total daily dose for at least 28 days prior to Day 1, in conjunction with a dopa decarboxylase inhibitor (e.g., L-Dopa/carbidopa or L-Dopa/benserazide) divided in at least 3 divided doses per day.
• years old
• Able to understand and cooperate with study procedures and give informed consent.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
• Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight of greater than or equal to 45kg.
• Native English speaker or demonstrated fluency in English.
• Normal or corrected-to-normal vision
• A score of greater than or equal to 26 on the Mini Mental State Examination (MMSE).
• A score of 49 on the Green Form of the WRAT-4 Word Reading Subtest (equivalent to 8th grade reading level)

You may not qualify if:

• Treatment with an investigational drug within 30 days of Day 1 of study activities.
• Diagnosis of moderate to severe alcohol use disorder within 6 months of the screening as disclosed by the subject
• Employees, student, or advisee of the Principal Investigator
• History of head injury with clinically significant sequelae (e.g. loss of consciousness for greater than 15 minutes).
• DSM-V diagnosis of current, or history of, neurological disease (except for Parkinson's disease), Schizophrenia Spectrum or Other Psychotic disorders, or Bipolar and Related Disorders as disclosed by the subject.
• Subjects with cardiac pacemakers, electronic pumps, or any other implanted medical devices, including deep brain stimulation devices.
• Women of childbearing age will be required to undergo a pregnancy test to rule out a possible pregnancy.
• Allergy to adhesives or silicone

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Evans Biomedical Research Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kevin C Thomas, PhD MBA

  BU Anatomy and Neurology Dept, Evans Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anatomy & Neurobiology

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 11, 2017
• Study Start: May 2, 2017
• Primary Completion: July 1, 2018
• Study Completion: January 22, 2019
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)