Acute and Long Term Effects of VNS on Memory in Patients With Refractory Epilepsy
Primary Purpose
Refractory Epilepsy
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Memory task
Sponsored by
About this trial
This is an interventional basic science trial for Refractory Epilepsy focused on measuring Vagus nerve stimulation, Transcutaneous vagus nerve stimulation, Word recognition paradigm
Eligibility Criteria
Inclusion Criteria:
- Refractory epilepsy
- Treated with vagus nerve stimulation
- IQ >= 70 and able to perform the memory task
Exclusion Criteria:
- IQ < 70
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Vagus nerve stimulation
Transcutaneous vagus nerve stimulation
Sham vagus nerve stimulation
Arm Description
Invasive vagus nerve stimulation
Cymba concha stimulation
No vagus nerve stimulation
Outcomes
Primary Outcome Measures
Immediate recall score at session 1
Free recall score for correctly recalled words (min score 0,max score 21, higher score indicates better performance), calculated as a percentage
Immediate recall score at session 2
Free recall score for correctly recalled words (min score 0, max score 21, higher score indicates better performance)), calculated as a percentage
Delayed recognition scores at session 1
Hitscore for correctly recognized target words (min score 0,max score 63, higher score indicates better performance), score for not recognized target words= misses (min score 0,max score 63, higher score indicates worse performance),correct rejection score of non-target related words (min score 0,max score 63, higher score indicates better performance), score for incorrect recognition of non-target related words= false alarms (min score 0,max score 63, higher score indicates worse performance), discrimination index= hit score -false alarm score (min score 0,max score 63, higher score indicates better performance). All scores are calculated as a percentage.
Delayed recognition scores at session 2
Hitscore for correctly recognized target words (min score 0,max score 48, higher score indicates better performance), score for not recognized target words= misses (min score 0,max score 48, higher score indicates worse performance),correct rejection score of non-target related words (min score 0,max score 48, higher score indicates better performance), score for incorrect recognition of non-target related words= false alarms (min score 0,max score 48, higher score indicates worse performance), discrimination index= hit score -false alarm score (min score 0,max score 48, higher score indicates better performance). All scores are calculated as a percentage.
Secondary Outcome Measures
Attention score at session 1
Score of correct responses on 6 open question (min score 0, max score 6, higher score indicates better performance), calculated as a percentage
Attention score at session 2
Score of correct responses on 6 open question (min score 0, max score 6, higher score indicates better performance), calculated as a percentage
Full Information
NCT ID
NCT05031208
First Posted
August 19, 2021
Last Updated
May 2, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05031208
Brief Title
Acute and Long Term Effects of VNS on Memory in Patients With Refractory Epilepsy
Official Title
Research on the Acute and Long Term Effects on Memory and the Mechanism of Action of Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
August 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Refractory epilepsy patients implanted with a vagus nerve stimulator perform a memory test at baseline in three conditions: invasive vagus nerve stimulation (VNS), transcutaneous vagus nerve stimulation (taVNS) and sham stimulation. After 6 weeks of VNS treatment, the memory test is repeated in two condition: invasive vagus nerve stimulation (VNS) and sham stimulation.
The endpoint of this experiment is assessing the effect of VNS and taVNS on memory performance.
Detailed Description
Previous studies underlined the potential of both invasive as transcutaneous auricular vagus nerve stimulation to ameliorate certain cognitive functions.
In this randomized, controlled cross-over within-subjects study, a memory test is conducted in patients with refractory epilepsy who are implanted with a vagus nerve stimulation.
The memory test consists out of a word recognition paradigm based on the study of Clarck et al. published in 1999 in Nature Neuroscience. Testing is performed at baseline (before start of the stimulation) and after 6 weeks of treatment with vagus nerve stimulation.
During the first session, the patients complete the word recognition task during three interventions:
Invasive vagus nerve stimulation
Transcutaneous vagus nerve stimulation (cymba concha)
Sham vagus nerve stimulation (no stimulation)
During the second session, the patients complete the word recognition task during two interventions:
Invasive vagus nerve stimulation
Sham vagus nerve stimulation (no stimulation)
The goal is to investigate if invasive vagus nerve stimulation and transcutaneous nerve stimulation can influence (i.e. improve) the performance on the memory task and if this performance is improved after 6 weeks of VNS treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy
Keywords
Vagus nerve stimulation, Transcutaneous vagus nerve stimulation, Word recognition paradigm
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vagus nerve stimulation
Arm Type
Experimental
Arm Description
Invasive vagus nerve stimulation
Arm Title
Transcutaneous vagus nerve stimulation
Arm Type
Experimental
Arm Description
Cymba concha stimulation
Arm Title
Sham vagus nerve stimulation
Arm Type
Sham Comparator
Arm Description
No vagus nerve stimulation
Intervention Type
Diagnostic Test
Intervention Name(s)
Memory task
Intervention Description
Word recognition task
Primary Outcome Measure Information:
Title
Immediate recall score at session 1
Description
Free recall score for correctly recalled words (min score 0,max score 21, higher score indicates better performance), calculated as a percentage
Time Frame
At baseline
Title
Immediate recall score at session 2
Description
Free recall score for correctly recalled words (min score 0, max score 21, higher score indicates better performance)), calculated as a percentage
Time Frame
After 6 weeks of VNS treatment
Title
Delayed recognition scores at session 1
Description
Hitscore for correctly recognized target words (min score 0,max score 63, higher score indicates better performance), score for not recognized target words= misses (min score 0,max score 63, higher score indicates worse performance),correct rejection score of non-target related words (min score 0,max score 63, higher score indicates better performance), score for incorrect recognition of non-target related words= false alarms (min score 0,max score 63, higher score indicates worse performance), discrimination index= hit score -false alarm score (min score 0,max score 63, higher score indicates better performance). All scores are calculated as a percentage.
Time Frame
At baseline
Title
Delayed recognition scores at session 2
Description
Hitscore for correctly recognized target words (min score 0,max score 48, higher score indicates better performance), score for not recognized target words= misses (min score 0,max score 48, higher score indicates worse performance),correct rejection score of non-target related words (min score 0,max score 48, higher score indicates better performance), score for incorrect recognition of non-target related words= false alarms (min score 0,max score 48, higher score indicates worse performance), discrimination index= hit score -false alarm score (min score 0,max score 48, higher score indicates better performance). All scores are calculated as a percentage.
Time Frame
After 6 weeks of VNS treatment
Secondary Outcome Measure Information:
Title
Attention score at session 1
Description
Score of correct responses on 6 open question (min score 0, max score 6, higher score indicates better performance), calculated as a percentage
Time Frame
At baseline
Title
Attention score at session 2
Description
Score of correct responses on 6 open question (min score 0, max score 6, higher score indicates better performance), calculated as a percentage
Time Frame
After 6 weeks of VNS treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Refractory epilepsy
Treated with vagus nerve stimulation
IQ >= 70 and able to perform the memory task
Exclusion Criteria:
IQ < 70
Facility Information:
Facility Name
University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
10195186
Citation
Clark KB, Naritoku DK, Smith DC, Browning RA, Jensen RA. Enhanced recognition memory following vagus nerve stimulation in human subjects. Nat Neurosci. 1999 Jan;2(1):94-8. doi: 10.1038/4600.
Results Reference
background
PubMed Identifier
25805212
Citation
Jacobs HI, Riphagen JM, Razat CM, Wiese S, Sack AT. Transcutaneous vagus nerve stimulation boosts associative memory in older individuals. Neurobiol Aging. 2015 May;36(5):1860-7. doi: 10.1016/j.neurobiolaging.2015.02.023. Epub 2015 Feb 28.
Results Reference
background
PubMed Identifier
29326067
Citation
Colzato LS, Ritter SM, Steenbergen L. Transcutaneous vagus nerve stimulation (tVNS) enhances divergent thinking. Neuropsychologia. 2018 Mar;111:72-76. doi: 10.1016/j.neuropsychologia.2018.01.003. Epub 2018 Jan 8.
Results Reference
background
PubMed Identifier
25869158
Citation
Steenbergen L, Sellaro R, Stock AK, Verkuil B, Beste C, Colzato LS. Transcutaneous vagus nerve stimulation (tVNS) enhances response selection during action cascading processes. Eur Neuropsychopharmacol. 2015 Jun;25(6):773-8. doi: 10.1016/j.euroneuro.2015.03.015. Epub 2015 Mar 30.
Results Reference
background
PubMed Identifier
35132096
Citation
Mertens A, Gadeyne S, Lescrauwaet E, Carrette E, Meurs A, De Herdt V, Dewaele F, Raedt R, Miatton M, Boon P, Vonck K. The potential of invasive and non-invasive vagus nerve stimulation to improve verbal memory performance in epilepsy patients. Sci Rep. 2022 Feb 7;12(1):1984. doi: 10.1038/s41598-022-05842-3.
Results Reference
derived
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Acute and Long Term Effects of VNS on Memory in Patients With Refractory Epilepsy
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