Status:
COMPLETED
eOnOff - D1 Extension
Lead Sponsor:
Boston University
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-75 years
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. W...
Detailed Description
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 approximate...
Eligibility Criteria
Inclusion
- 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.
- 45-75 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 2 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 22 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03247387
Start Date
May 2 2017
End Date
January 22 2019
Last Update
January 24 2019
Active Locations (1)
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1
Evans Biomedical Research Center
Boston, Massachusetts, United States, 02118