- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539506
Cross Modal Correlation of EEG and MRI Functional Connectivity: An Investigative Study
Study Overview
Detailed Description
Cross modal correlation of EEG and MRI functional connectivity: An Investigative Study. Correlating EEG Analysis with Brain Network Connectivity in fMRI. The primary aim of this study is to correlate correlation of MRI and EEG. The expected study duration is approximately 24 months (first patient in to last patient out). Estimated Enrolment: 1500 Subjects.
The aim of this study is to correlate between fMRI and EEG. Overall, the integration of AI into the study of correlations between EEG and fMRI for brain network analysis holds great promise for advancing our understanding of brain function.
Upon consent, eligible participants will be invited for EEG evaluation. EEG will be obtained using a dry electrodes headset. Correlation between fMRI and EEG connectivity for each EEG frequency band across different configurations (brain atlas, EEG connectivity measure).
EEG data will undergo pre-processing of filtering, electrical line noise removal, artifact removal and down sampling. EEG analysis for each state, comprising within and between participant data, will include frequency analysis (peak frequency and relative power), oscillations (proportions of the activity of the alpha, beta, theta, and delta bands) and power spectra distribution. Functional connectivity analysis will be performed including functional coupling.
For evoked response potentials analysis, data will be segmented to trials/epochs. Bad trials will be excluded from analysis. Included trials data will be averaged. Event-related synchronization (ERS) / desynchronization (ERD) will be evaluated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shai Efrati, MD
- Phone Number: 972509212866
- Email: efratishai@outlook.com
Study Locations
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Zrifin, Israel, 70300
- Recruiting
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
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Contact:
- Shai Efrati, Prof
- Phone Number: 972-8-9779393
- Email: efratishai@outlook.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or females aged 18 years or older.
- Performed a brain MRI at the Sagol Center MRI Unit, at the Shamir Medical Center
- Able to cooperate in an EEG evaluation
- Can read and sign the informed consent.
Exclusion Criteria:
- Any scalp/bone abnormality incompatible with the EEG electrodes
- Any known allergy to metals.
- Inability to cooperate with simple instructions.
- Inability to read and sign the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Electroencephalography (EEG)
EEG excels in capturing rapid changes in neural activity, making it ideal for investigating the dynamic nature of brain networks.
It can detect millisecond-level fluctuations in electrical brain signals, allowing precise timing of neural events and interactions between brain regions.
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EEG uses small sensors paced on the scalp to record the brain's electrical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation of fMRI and EEG functional connectivity.
Time Frame: The expected study duration is approximately 24 months (first patient in to last patient out)
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Examines how brain connectivity patterns measured by fMRI (blood-flow activity) relate to connectivity patterns measured by EEG (electrical activity).
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The expected study duration is approximately 24 months (first patient in to last patient out)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between EEG to anatomical MRI findings
Time Frame: The expected study duration is approximately 24 months (first patient in to last patient out)
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Investigates how electrical brain activity (EEG) corresponds to structural brain features or abnormalities seen on anatomical MRI.
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The expected study duration is approximately 24 months (first patient in to last patient out)
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Correlation between EEG to clinical diagnosis, cognitive and physical parameters.
Time Frame: The expected study duration is approximately 24 months (first patient in to last patient out)
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Explores how EEG findings relate to a patient's medical diagnosis, cognitive functioning (e.g., memory, attention), and physical/neurological condition.
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The expected study duration is approximately 24 months (first patient in to last patient out)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shai Efrati, MD, Study Principal Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0287-23-ASF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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