Parkinson DiseaseNCT02149498
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
An observational study of Parkinson Disease, run by Dr. Oren Cohen.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients with idiopathic Parkinson's disease (PD) 50 Healthy controls (HC)
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Keywords
- Parkinson, EEG, BNA
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Oren Cohen
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. Oren Cohen, Sheba Medical Center
- Investigators
- Sharon Hassin, Dr., Study director, Sheba Medical CenterOren Cohen, Dr., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149498
- Sponsor's protocol ID
- PD-MAG-01
- Status last verified
- Apr 2014
- First submitted
- 26 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02149498
- Acronym / sponsor ID
- PD-MAG-01
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, EEG, BNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Oren CohenOther government
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with idiopathic Parkinson's disease (PD) 50 Healthy controls (HC)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Hassin, Dr. study director
Sheba Medical Center
Oren Cohen, Dr. principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Dr. Oren Cohen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naama Warman Alaluf, Msc (972-3-530-4931, naama.warmanalaluf@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional networks of brain activity in Idiopathic PD patients and healthy individuals measured using analysis of EEG Event Related Potential (time frame: 2 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014; AzTrials last refreshed its copy on 1 Nov 2026.