NCT02132507

Brief Summary

The purpose of the study is to evaluate a new technology for functional neuroimaging using electroencephalography (EEG) and MRI in studying epilepsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

4.4 years

First QC Date

May 5, 2014

Last Update Submit

January 18, 2018

Conditions

Epilepsy

Keywords

epilepsyfMRIEEGICA

Outcome Measures

Primary Outcomes (1)

  • Localization of epileptogenic foci

    Finding of epileptogenic foci in patients with focal epilepsy

    12/31/2014

Eligibility Criteria

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

Patients who are seen at the epilepsy center of School of medicine, University of Minnesota

You may qualify if:

  • \. Patients are diagnosed with medically intractable epilepsy;
  • \. patients have frequent interictal spikes on clinical EEG monitorings;
  • \. patients without large morphological abnormalities

You may not qualify if:

  • Patients with skull bony defects, intracerebral mass lesions, major brain malformations, large cystic regions will be excluded.
  • Any indwelling metal objects or implantable devices such as pace makers, cochlear implants, or implanted intracranial electrodes.
  • Patients with claustrophobia.
  • Patients with more than 2 grand mal seizures per month.
  • Patients will not be excluded on the basis of location of seizure onset zone, type or number of medications, or cognitive status (assuming the minimum criteria has been met), or race.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Engineering Department

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bin He, PhD

    Distinguished McKnight University Professor of Biomedical Engineering Medtronic-Bakken Chair for Engineering in Medicine Director, Institute for Engineering in Medicine Director, Center for Neuroengineering

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

January 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

US(1)