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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

NCT03595072 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-06-07

No results posted yet for this study

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.

Conditions

Interventions

OTHER

observation of VNS stimulation effects

ECOGs will be recorded during VNS stimulation and inter stimulation periods

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Samuel Destefano, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-01-01
Completion
2025-01-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595072 on ClinicalTrials.gov