NCT04753983

Brief Summary

The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1.7 years

First QC Date

February 9, 2021

Last Update Submit

October 28, 2022

Conditions

Refractory Epilepsy

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Document brain activation networks with ANT stimulation

    Use resting state fMRI to map brain network activation with high and low frequency of ANT stimulation.

    Results would be available immediately following processing of the imaging data after each scan

Study Arms (1)

Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS)

EXPERIMENTAL

Subjects that have undergone DBS placement for treatment of refractory epilepsy will undergo a fMRI scan. During the fMRI, the subject will undergo alternating short periods of their DBS in the "on" and "off" state with high- and low frequency settings to measure the brain activation changes induced by the DBS.

Diagnostic Test: Functional magnetic resonance imaging (fMRI)

Interventions

Functional magnetic resonance imaging (fMRI)DIAGNOSTIC_TEST

Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity

Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS)

Eligibility Criteria

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

You may qualify if:

  • \- Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.

You may not qualify if:

  • \- Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Steven A Messina, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

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

February 9, 2021

First Posted

February 15, 2021

Study Start

September 1, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

November 1, 2022

Record last verified: 2022-10