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

Not Applicable

Terminated

• Conditions: Refractory Epilepsy
• Interventions: Other: beta (25-30 Hz); Other: no stimulation; Other: Theta (5 Hz)

• Registration Number: NCT03331939
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2017-01-06
• Status Verified: 2017-10
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-01
• Last Update Submitted: 2017-11-01
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Beta (25-30 Hz)	beta (25-30 Hz)	Vagal nerve stimulator will be set to Beta (25-30 Hz)
No stimulation	no stimulation	All patients will receive three different stimulations
Theta (5 Hz)	Theta (5 Hz)	Vagal nerve stimulator will be set to Theta (5 Hz)

Primary Outcome Measures

Name	Time	Method
California Verbal and Learning Test 2nd edition group 3	hour 3	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 1	hour 1.5	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	hour 2.25	Test scored with lower values indicating worse memory and higher values indicating better memory.; Minimum Value: -16; Maximum Value: 16