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Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baseline
visual stimuli
Auditory stimuli
Visual and auditory stimuli
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Patients with Parkinson's disease that are ambulatory and can sign a written informed consent

Exclusion Criteria:

  • Patients with Parkinson's disease who are not ambulatory
  • Patients with dementia
  • Patients that are blind
  • Patients that have severe hearing impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Baseline

    Visual stimuli

    Auditory stimuli

    Visual and auditory stimuli

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2016
    Last Updated
    June 6, 2016
    Sponsor
    Rambam Health Care Campus
    Collaborators
    Technion, Israel Institute of Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02768896
    Brief Title
    Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients
    Official Title
    Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rambam Health Care Campus
    Collaborators
    Technion, Israel Institute of Technology

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device.
    Detailed Description
    Patients with Parkinson's disease may have gait disturbances including freezing of gait. Visual and auditory stimuli may improve gait. Investigators will analyze brain wave during walking while giving the subject different stimuli. The voltage fluctuation (in hundreds of microvolts) will be recorded using the EEG cap and amplifier into a computer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Baseline
    Arm Type
    No Intervention
    Arm Description
    Patients will walk naturally with EEG measuring brain waves
    Arm Title
    Visual stimuli
    Arm Type
    Experimental
    Arm Description
    Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
    Arm Title
    Auditory stimuli
    Arm Type
    Experimental
    Arm Description
    Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
    Arm Title
    Visual and auditory stimuli
    Arm Type
    Experimental
    Arm Description
    Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously
    Intervention Type
    Behavioral
    Intervention Name(s)
    Baseline
    Intervention Description
    Patients will walk naturally with EEG measuring brain waves
    Intervention Type
    Behavioral
    Intervention Name(s)
    visual stimuli
    Intervention Description
    Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
    Intervention Type
    Behavioral
    Intervention Name(s)
    Auditory stimuli
    Intervention Description
    Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
    Intervention Type
    Behavioral
    Intervention Name(s)
    Visual and auditory stimuli
    Intervention Description
    Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously
    Primary Outcome Measure Information:
    Title
    Voltage fluctuation resulting from brain activity after visual stimuli
    Description
    Change in brain wave activity after visual stimuli as compared with baseline measured in tens of micro-volts per second.
    Time Frame
    One hour
    Title
    Voltage fluctuation resulting from brain activity after auditory stimuli
    Description
    Change in brain wave activity after auditory stimuli as compared with baseline measured in tens of micro-volts per second.
    Time Frame
    One hour
    Title
    Voltage fluctuation resulting from brain activity after visual and auditory stimuli
    Description
    Change in brain wave activity after visual and auditory stimuli as compared with baseline measured in tens of micro-volts per second.
    Time Frame
    One hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Patients with Parkinson's disease that are ambulatory and can sign a written informed consent Exclusion Criteria: Patients with Parkinson's disease who are not ambulatory Patients with dementia Patients that are blind Patients that have severe hearing impairment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ilana Schlesinger, MD
    Phone
    972502062529
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ilana Schlesinger, MD
    Organizational Affiliation
    Rambam Health Care Campus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients

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