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

NCT ID: NCT02149498

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

Healthy Controls

Healthy individuals

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Oren Cohen

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Oren Cohen

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sharon Hassin, Dr.

Role: STUDY_DIRECTOR

Sheba Medical Center

Oren Cohen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Central Contacts

Naama Warman Alaluf, Msc

Role: CONTACT

naama.warmanalaluf@sheba.health.gov.il

972-3-530-4931

Other Identifiers

PD-MAG-01

Identifier Type: -

Identifier Source: org_study_id