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

Parkinson Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02149498
• Other study ID #: PD-MAG-01
• Status: Not yet recruiting
• Phase: N/A
• First received: May 26, 2014
• Last updated: May 26, 2014
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: April 2014
• Source: Sheba Medical Center
• Contact: Naama Warman Alaluf, Msc
• Phone: 972-3-530-4931
• Email: naama.warmanalaluf[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Oren Cohen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional networks of brain activity in Idiopathic PD patients and healthy individuals measured using analysis of EEG Event Related Potential	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	No