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

September 21, 2018

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:

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

 

Estimated study start date: August 1, 2018
Estimated study completion date: December 1, 2018

Eligibility Criteria:

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

Inclusion Criteria:

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

 

Exclusion Criteria:

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