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

November 1, 2017 updated by: Kiarash Shahlaie, M.D., Ph.D., University of California, Davis

Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition : a Pilot Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
hour 1.5
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
hour 2.25
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
hour 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2017

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 938884

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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