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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03331939

Enrollment

Registered

2017-11-06

Start date

2017-01-06

Completion date

2017-10-31

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Epilepsy

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.

Interventions

OTHERno stimulation

Vagal nerve stimulator will be set to no stimulation

OTHERbeta (25-30 Hz)

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

OTHERTheta (5 Hz)

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Pilot Study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026