NCT03870308

Brief Summary

Researchers are trying to incorporate a process known as Functional MRI (fMRI) scanning to reveal a pattern in brain activity during Deep Brain Stimulation (DBS), which will correlate to possible seizure freedom.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration 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

March 5, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

March 8, 2019

Last Update Submit

September 13, 2021

Conditions

Epilepsy

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • DBS Stimulation

    The primary endpoint of this feasibility study is detection of functional MRI activation related to DBS stimulation.

    One year

Study Arms (1)

Deep Brain Stimulation subjects

EXPERIMENTAL
Diagnostic Test: Functional MRI

Interventions

Functional MRIDIAGNOSTIC_TEST

A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.

Deep Brain Stimulation subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients selected to undergo anterior thalamic nucleus DBS for refractory epilepsy

You may not qualify if:

  • Contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Epilepsy

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Erik H Middlebrooks

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 12, 2019

Study Start

March 5, 2019

Primary Completion

December 31, 2020

Study Completion

January 11, 2021

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

US(1)