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Assessment of Effect of Vagal Nerve Stimulator (VNS) on Electrocorticograms Recorded by Responsive Neurostimulator (RNS) in Patients With Drug Resistant Epilepsy

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ClinicalTrials.gov Identifier: NCT03595072
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

This study will investigate whether a Vagal Nerve Stimulator (VNS) causes measurable desynchronization and reduces epileptiform activity, such as spikes and seizures, in electrocorticograms (ECOGs) recorded by a Responsive Neurostimulator (RNS) in patients who have both devices implanted.

Specific aims of the study:

  1. Evaluate the change in frequency of epileptiform discharges during active VNS stimulation compared to interstimulation baseline periods
  2. Evaluate the change in frequency of seizures during active VNS stimulation compared to interstimulation baseline periods
  3. Evaluate the change in the number of RNS activations during active VNS stimulation compared to interstimulation baseline periods
  4. Evaluate the change in synchronization of background ECoG (electrocorticogram) during VNS stimulation compared to interstimulation baseline periods.

Condition or disease Intervention/treatment
Epilepsy Other: observation of VNS stimulation effects

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Effect of Vagal Nerve Stimulator (VNS) on Electrocorticograms Recorded by Responsive Neurostimulator (RNS) in Patients With Drug Resistant Epilepsy
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Stimulation
patient ECOG recordings during active VNS stimulation
Other: observation of VNS stimulation effects
ECOGs will be recorded during VNS stimulation and inter stimulation periods

interstimulation
the same patient ECOG during inter-stimulation periods



Primary Outcome Measures :
  1. Change in frequency of epileptiform discharges during active VNS stimulation and during interstimulation baseline periods [ Time Frame: 1 day of clinic appointment ]
  2. Change in frequency of seizures during active VNS stimulation and during interstimulation baseline periods [ Time Frame: 1 day of clinic appointment ]
  3. Change in the number of RNS activations during active VNS stimulation and during interstimulation baseline periods [ Time Frame: 1 day of clinic appointment ]
  4. Change in synchronization of background ECoG (electrocorticogram) during VNS stimulation. [ Time Frame: 1 day of clinic appointment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a pilot study which plans to enroll all current patients with both VNS and RNS with potential to enroll further participants as more patients have both devices implanted.
Criteria

INCLUSION CRITERIA:

  1. A patient of the University of Colorado Hospital Epilepsy clinic;
  2. Have had either VNS and/or RNS implanted;
  3. Age 18 years to 75 years.

EXCLUSION CRITERIA:

  1. Not capable of making a medical decision;
  2. Unable to comprehend study details, or
  3. Unable to adequately communicate secondary to intellectual or language barrier.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595072


Contacts
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Contact: Samuel Destefano, MD (720) 848-2080 samuel.destefano@ucdenver.edu

Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Samuel Destefano, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03595072     History of Changes
Other Study ID Numbers: 17-0578
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases