Study Stopped
insufficient study staff
Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition in Patients With Refractory Epilepsy
1 other identifier
interventional
2
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedFirst Submitted
Initial submission to the registry
November 1, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedNovember 6, 2017
October 1, 2017
10 months
November 1, 2017
November 1, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (3)
No stimulation
EXPERIMENTALAll patients will receive three different stimulations
Beta (25-30 Hz)
OTHERVagal nerve stimulator will be set to Beta (25-30 Hz)
Theta (5 Hz)
OTHERVagal nerve stimulator will be set to Theta (5 Hz)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Refractory Epilepsy
- Previously implanted vagal nerve stimulator
- Willingness and ability to undergo temporary changes to their VNS device settings
You may not qualify if:
- \<18 years of age
- Adults unable to consent
- Pregnant women
- Prisoners
- \>20 on the Beck Depression Inventory (BDI)
- \<24 on the Montreal Cognitive Assessment (MOCA)
- Adults with diagnosis of developmental delay, intellectual disability, or traumatic brain injury (TBI).
- Adults with reported history of learning disability.
- Adults unable to use a computer with their dominant hand.
- Status Epilepticus within the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 1, 2017
First Posted
November 6, 2017
Study Start
January 6, 2017
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
November 6, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share