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

June 6, 2016 updated by: Rambam Health Care Campus
Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Baseline
Patients will walk naturally with EEG measuring brain waves
Experimental: Visual stimuli
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
Behavioral: Baseline
Patients will walk naturally with EEG measuring brain waves
Behavioral: visual stimuli
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
Experimental: Auditory stimuli
Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
Behavioral: Baseline
Patients will walk naturally with EEG measuring brain waves
Behavioral: Auditory stimuli
Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
Experimental: Visual and auditory stimuli
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously
Behavioral: Baseline
Patients will walk naturally with EEG measuring brain waves
Behavioral: Visual and auditory stimuli
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voltage fluctuation resulting from brain activity after visual stimuli
Time Frame: One hour
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
Time Frame: One hour
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
Time Frame: One hour
Change in brain wave activity after visual and auditory stimuli as compared with baseline measured in tens of micro-volts per second.
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

Technion, Israel Institute of Technology

Investigators

  • Principal Investigator: Ilana Schlesinger, MD, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0182-16RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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