Acute and Long Term Effects of VNS on Memory in Patients With Refractory Epilepsy
NCT ID: NCT05031208
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-11-22
2020-08-28
Brief Summary
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The endpoint of this experiment is assessing the effect of VNS and taVNS on memory performance.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Vagus nerve stimulation
Invasive vagus nerve stimulation
Memory task
Word recognition task
Transcutaneous vagus nerve stimulation
Cymba concha stimulation
Memory task
Word recognition task
Sham vagus nerve stimulation
No vagus nerve stimulation
Memory task
Word recognition task
Interventions
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Memory task
Word recognition task
Eligibility Criteria
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Inclusion Criteria
* Treated with vagus nerve stimulation
* IQ \>= 70 and able to perform the memory task
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Locations
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University Hospital
Ghent, , Belgium
Countries
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References
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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.
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.
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.
Steenbergen L, Sellaro R, Stock AK, Verkuil B, Beste C, Colzato LS. RETRACTED: 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.
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.
Other Identifiers
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EC/2016/0786
Identifier Type: -
Identifier Source: org_study_id
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