Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJune 7, 2016
June 1, 2016
1.6 years
April 4, 2016
June 6, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Voltage fluctuation resulting from brain activity after visual stimuli
Change in brain wave activity after visual stimuli as compared with baseline measured in tens of micro-volts per second.
One hour
Voltage fluctuation resulting from brain activity after auditory stimuli
Change in brain wave activity after auditory stimuli as compared with baseline measured in tens of micro-volts per second.
One hour
Voltage fluctuation resulting from brain activity after visual and auditory stimuli
Change in brain wave activity after visual and auditory stimuli as compared with baseline measured in tens of micro-volts per second.
One hour
Study Arms (4)
Baseline
NO INTERVENTIONPatients will walk naturally with EEG measuring brain waves
Visual stimuli
EXPERIMENTALPatients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
Auditory stimuli
EXPERIMENTALPatients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
Visual and auditory stimuli
EXPERIMENTALPatients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously
Interventions
Patients will walk naturally with EEG measuring brain waves
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously
Eligibility Criteria
You may qualify if:
- Patients with Parkinson's disease that are ambulatory and can sign a written informed consent
You may not qualify if:
- Patients with Parkinson's disease who are not ambulatory
- Patients with dementia
- Patients that are blind
- Patients that have severe hearing impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilana Schlesinger, MD
Rambam Health Care Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2016
First Posted
May 11, 2016
Study Start
June 1, 2016
Primary Completion
January 1, 2018
Study Completion
February 1, 2018
Last Updated
June 7, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share