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

Primary Purpose

Refractory Epilepsy

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
no stimulation
beta (25-30 Hz)
Theta (5 Hz)
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Other

    Other

    Arm Label

    No stimulation

    Beta (25-30 Hz)

    Theta (5 Hz)

    Arm Description

    All patients will receive three different stimulations

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

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

    Outcomes

    Primary Outcome Measures

    California Verbal and Learning Test 2nd edition group 1
    Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
    California Verbal and Learning Test 2nd edition group 2
    Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
    California Verbal and Learning Test 2nd edition group 3
    Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2017
    Last Updated
    November 1, 2017
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03331939
    Brief Title
    Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition in Patients With Refractory Epilepsy
    Official Title
    Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition : a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    insufficient study staff
    Study Start Date
    January 6, 2017 (Actual)
    Primary Completion Date
    October 31, 2017 (Actual)
    Study Completion Date
    October 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractory Epilepsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pilot Study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No stimulation
    Arm Type
    Experimental
    Arm Description
    All patients will receive three different stimulations
    Arm Title
    Beta (25-30 Hz)
    Arm Type
    Other
    Arm Description
    Vagal nerve stimulator will be set to Beta (25-30 Hz)
    Arm Title
    Theta (5 Hz)
    Arm Type
    Other
    Arm Description
    Vagal nerve stimulator will be set to Theta (5 Hz)
    Intervention Type
    Other
    Intervention Name(s)
    no stimulation
    Intervention Description
    Vagal nerve stimulator will be set to no stimulation
    Intervention Type
    Other
    Intervention Name(s)
    beta (25-30 Hz)
    Intervention Description
    Vagal nerve stimulator will be set to beta (25-30 Hz)
    Intervention Type
    Other
    Intervention Name(s)
    Theta (5 Hz)
    Intervention Description
    Vagal nerve stimulator will be set to beta (5 Hz)
    Primary Outcome Measure Information:
    Title
    California Verbal and Learning Test 2nd edition group 1
    Description
    Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
    Time Frame
    hour 1.5
    Title
    California Verbal and Learning Test 2nd edition group 2
    Description
    Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
    Time Frame
    hour 2.25
    Title
    California Verbal and Learning Test 2nd edition group 3
    Description
    Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
    Time Frame
    hour 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Refractory Epilepsy Previously implanted vagal nerve stimulator Willingness and ability to undergo temporary changes to their VNS device settings Exclusion Criteria: <18 years of age Adults unable to consent Pregnant women Prisoners >20 on the Beck Depression Inventory (BDI) <24 on the Montreal Cognitive Assessment (MOCA) Adults with diagnosis of developmental delay, intellectual disability, or traumatic brain injury (TBI). Adults with reported history of learning disability. Adults unable to use a computer with their dominant hand. Status Epilepticus within the past 6 months

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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