NCT02193932

Brief Summary

A prospective exploratory study in patients with drug resistant epilepsy with a target comparison of long term outcome. NeuroScan software modules and a MagLink will be used to acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the MRI machine, without compromising the raw EEG data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

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

February 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

6.5 years

First QC Date

July 10, 2014

Last Update Submit

September 19, 2019

Conditions

Epilepsy

Keywords

EEG triggeredfMRIepilepsyintractable

Outcome Measures

Primary Outcomes (1)

  • Number of participants with at least 40 interictal epileptic discharges during the fMRI

    1 year

Study Arms (1)

EEG Triggered fMRI using Micro Maglink

EXPERIMENTAL

EEG Triggered fMRI to be performed using the Micro Maglink

Other: EEG Triggered fMRI using Micro Maglink

Interventions

EEG Triggered fMRI using Micro MaglinkOTHER
EEG Triggered fMRI using Micro Maglink

Eligibility Criteria

Age1 Year - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Refractory epilepsy cases, referred by the service of Neurology. These are cases whose pathophysiology is resistant to treatment, including change in medication and or added medication.
  • Patients will be included if they agree to sign an Institutional Review Board approved written consent.

You may not qualify if:

  • Patients with overt symptoms or signs of anxiety than cannot cooperate during the recording inside the scanner, unless consent is given for the procedure to be performed with sedation by the anesthesia department.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baptist Hospital

Miami, Florida, 33173, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sergio Gonzalez-Arias, MD

    Baptist Health South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 18, 2014

Study Start

February 1, 2013

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations

US(1)