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Clinical Trials/NCT02149498
NCT02149498
Unknown
Not Applicable

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

Dr. Oren Cohen0 sites100 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Dr. Oren Cohen
Enrollment
100
Primary Endpoint
Functional networks of brain activity in Idiopathic PD patients and healthy individuals measured using analysis of EEG Event Related Potential
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
July 2016
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr. Oren Cohen
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Oren Cohen

MD

Sheba Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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.

Outcomes

Primary Outcomes

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

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