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

Refractory Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03331939
• Other study ID #: 938884
• Status: Terminated
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 1, 2017
• Start date: January 6, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: October 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Other:
• no stimulation
Vagal nerve stimulator will be set to no stimulation
• beta (25-30 Hz)
Vagal nerve stimulator will be set to beta (25-30 Hz)
• Theta (5 Hz)
Vagal nerve stimulator will be set to beta (5 Hz)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hour 1.5
Primary	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	hour 2.25
Primary	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	hour 3