Mapping Functional Networks of Brain Activity (Brain Network Activation, BNA) Based on Analysis of Evoked Response Potential (ERP) Signals for Healthy Controls Evoked Response Potential (ERP) Signals for Healthy Controls and Patients With Parkinson Disease

May 26, 2014 updated by: Dr. Oren Cohen
A cornerstone in PD research is the investigation of neurophysiological changes as potential biomarkers that could help in tracking disease progression and response to therapies. Electroencephalography (EEG) could provide a non-invasive and relatively cheap tool for identification of such biomarkers. In this study we will use high-density electroencephalograph (EEG) recording, in order to develop a platform of biomarkers that could be more sensitive and reliable to disease progression and response to therapeutic intervention than standard clinical measures.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 patients with idiopathic Parkinson's disease (PD) 50 Healthy controls (HC)

Description

Inclusion Criteria:

  1. Idiopathic PD patients (according to the UK PD Society brain bank clinical diagnostic criteria (bradykinesia plus at least one other cardinal feature of PD, no atypical features or secondary cause) and HC aged 40-80 years
  2. PD patients Hoehn and Yahr stages I to IVStable PD therapy

Exclusion Criteria:

  • In the investigator's opinion, any unstable or clinically significant condition that would impair the participants' ability to comply with study requirements.
  • Patients or HC with significant psychiatric symptoms or history
  • BDI score <14
  • MMSE <25
  • Treatment with neuroleptics.
  • For PD patients: Hoehn and Yahr Stage 5
  • PD Patients with severe dyskinesia or tremor
  • PD Patients with atypical Parkinsonism or secondary Parkinsonism
  • History or evidence of neurological problems: cerebrovascular disease, previous head injury or neurosurgical interventions.
  • Currently with lice or open wounds on scalp.
  • Significant sensory deficits, e.g., deafness or blindness
  • Current drug abuse or alcoholism.
  • Pregnancy or not using a reliable method of birth control.
  • Participation in current clinical study or clinical study within 30 days prior to this study.

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

Cohorts and Interventions

Group / Cohort
Parkinson Disease (PD)
Idiopathic PD patients (according to the UK PD Society brain bank clinical diagnostic criteria (bradykinesia plus at least one other cardinal feature of PD, no atypical features or secondary cause)
Healthy Controls
Healthy individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional networks of brain activity in Idiopathic PD patients and healthy individuals measured using analysis of EEG Event Related Potential
Time Frame: 2 WEEKS
The study outcome measure are functional networks of brain activity of PD patients and healthy individuals established based on an analysis of EEG data recorded while study subjects perform ERP tasks
2 WEEKS

Collaborators and Investigators

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

Sponsor

Dr. Oren Cohen

Investigators

  • Study Director: Sharon Hassin, Dr., Sheba Medical Center
  • Principal Investigator: Oren Cohen, Dr., Sheba Medical Center

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

July 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-MAG-01

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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