Functional Brain Mapping for Patients with Epilepsy
Functional Brain Mapping in Pediatric Neurosurgery
1 other identifier
interventional
80
1 country
2
Brief Summary
We aim to determine the clinical utility of 'dynamic tractography': a novel method for visualizing electrical neural transfers that incorporates the underlying white matter tracts and supporting linguistic processing. We will also determine how well objective electrophysiology biomarkers will improve the prediction of language outcomes following epilepsy surgery. This project will ultimately optimize understanding of how the human brain develops its language network dynamics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2022
CompletedFirst Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
February 26, 2025
February 1, 2025
4.8 years
February 22, 2023
February 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Language outcome
Neuropsychological scores
1 year
Secondary Outcomes (1)
Seizure outcome
1 year
Study Arms (1)
Patients with epilepsy
OTHEREpilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy.
Interventions
Epilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy.
Eligibility Criteria
You may qualify if:
- Epilepsy surgery with extraoperative intracranial EEG recording with subdural or depth electrodes.
You may not qualify if:
- Patients with a malignant brain tumor, or progressive neurodegenerative or metabolic disorders who are not considered candidates for intracranial EEG recording.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Wayne State University
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eishi Asano, MD, PhD
Wayne State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics and Neurology
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 6, 2023
Study Start
May 16, 2022
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
February 26, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Once the primary findings have been published, we will make the data available.
Following data de-identification, we propose to share our datasets with the public via 'NeuroElectroMagnetic Data Archive and Tools Resource (NEMAR)' or 'iEEG.org', both of which are NIH-funded data-sharing platforms.