NCT05140265

Brief Summary

This proposal outlines the steps required for the creation of a pilot database of EEG recordings and de-identified medical records from patients internally referred within the UNMH Comprehensive Epilepsy Center. The UNMH EEG Corpus would be the first database of its kind. Other public databases contain either patient EEG signals or medical records, but without both kinds of information, it is impossible to relate pre-treatment neurobiomarkers with post-treatment prognosis. The database will also contain information that can improve seizure localization based off of scalp and intracranial EEG, and the requisite data for the creation of algorithms that forecast seizure activity; a development that could ultimately lead to novel responsive neural stimulation procedures that suppress seizures before they begin.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress50%
Oct 2021Dec 2030

Study Start

First participant enrolled

October 11, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

6.7 years

First QC Date

November 17, 2021

Last Update Submit

June 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • UNMH EEG Corpus

    Fully de-identified database creation matching between EEG and clinical data for adult patients of 18 years or older who underwent EEG study at UNMH from 2007 till 2027

    2007-2027

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of18 years old or older who has had EEG done at University of New Mexico with Nihon Kohden Neuroworkbench from 2007 till 2027.

You may not qualify if:

  • years old or older. If the patient's age is over 89, we will aggregated them to age 90 or older so that the patient cannot be identified. Also, all the EEG data will be de-identified and only show the year of the study performed instead of the exact study date to reduce the risk of identification. Of note, we perform over few thousands of EEG studies per year and it will be almost impossible to identify the patient based on the study year.
  • Children under age of 18 years old will be excluded.
  • Mismatched patients between EEG database and EMR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Health Science

Albuquerque, New Mexico, 87106, United States

RECRUITING

MeSH Terms

Conditions

EpilepsyStatus EpilepticusSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 1, 2021

Study Start

October 11, 2021

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations