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Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition in Patients With Refractory Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331939
Recruitment Status : Terminated (insufficient study staff)
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Kiarash Shahlaie, M.D., Ph.D., University of California, Davis

Brief Summary:
The purpose of this investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency VNS will have a positive effect on memory retention. The goal of this study to provide initial data to inform the design of a larger clinical trial to examine the efficacy of theta VNS.

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Other: no stimulation Other: beta (25-30 Hz) Other: Theta (5 Hz) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition : a Pilot Study
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: No stimulation
All patients will receive three different stimulations
Other: no stimulation
Vagal nerve stimulator will be set to no stimulation

Beta (25-30 Hz)
Vagal nerve stimulator will be set to Beta (25-30 Hz)
Other: beta (25-30 Hz)
Vagal nerve stimulator will be set to beta (25-30 Hz)

Theta (5 Hz)
Vagal nerve stimulator will be set to Theta (5 Hz)
Other: Theta (5 Hz)
Vagal nerve stimulator will be set to beta (5 Hz)




Primary Outcome Measures :
  1. California Verbal and Learning Test 2nd edition group 1 [ Time Frame: hour 1.5 ]

    Test scored with lower values indicating worse memory and higher values indicating better memory.

    Minimum Value:

    -16

    Maximum Value:

    16


  2. California Verbal and Learning Test 2nd edition group 2 [ Time Frame: hour 2.25 ]

    Test scored with lower values indicating worse memory and higher values indicating better memory.

    Minimum Value:

    -16

    Maximum Value:

    16


  3. California Verbal and Learning Test 2nd edition group 3 [ Time Frame: hour 3 ]

    Test scored with lower values indicating worse memory and higher values indicating better memory.

    Minimum Value:

    -16

    Maximum Value:

    16




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Refractory Epilepsy
  2. Previously implanted vagal nerve stimulator
  3. Willingness and ability to undergo temporary changes to their VNS device settings

Exclusion Criteria:

  1. <18 years of age
  2. Adults unable to consent
  3. Pregnant women
  4. Prisoners
  5. >20 on the Beck Depression Inventory (BDI)
  6. <24 on the Montreal Cognitive Assessment (MOCA)
  7. Adults with diagnosis of developmental delay, intellectual disability, or traumatic brain injury (TBI).
  8. Adults with reported history of learning disability.
  9. Adults unable to use a computer with their dominant hand.
  10. Status Epilepticus within the past 6 months
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Responsible Party: Kiarash Shahlaie, M.D., Ph.D., Associate Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT03331939    
Other Study ID Numbers: 938884
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
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
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases