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
About this trial
This is an interventional treatment trial for Refractory Epilepsy
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
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
NCT ID
NCT03331939
First Posted
November 1, 2017
Last Updated
November 1, 2017
Sponsor
University of California, Davis
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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