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

NCT ID: NCT03331939

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-06

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Refractory Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Pilot Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No stimulation

All patients will receive three different stimulations

Group Type EXPERIMENTAL

no stimulation

Intervention Type OTHER

Vagal nerve stimulator will be set to no stimulation

Beta (25-30 Hz)

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

Group Type OTHER

beta (25-30 Hz)

Intervention Type OTHER

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

Theta (5 Hz)

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

Group Type OTHER

Theta (5 Hz)

Intervention Type OTHER

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

Interventions

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no stimulation

Vagal nerve stimulator will be set to no stimulation

Intervention Type OTHER

beta (25-30 Hz)

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

Intervention Type OTHER

Theta (5 Hz)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Kiarash Shahlaie, M.D., Ph.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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938884

Identifier Type: -

Identifier Source: org_study_id