Acute and Long Term Effects of VNS on Memory in Patients With Refractory Epilepsy

NCT05031208 | Completed

• 1 other identifier: EC/2016/0786
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Epilepsy

Keywords

Vagus nerve stimulation; Transcutaneous vagus nerve stimulation; Word recognition paradigm

Outcome Measures

Primary Outcomes (4)

• 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

  At baseline

• 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

  After 6 weeks of VNS treatment

• 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.

  At baseline

• 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.

  After 6 weeks of VNS treatment

Secondary Outcomes (2)

• Attention score at session 1

  At baseline

• Attention score at session 2

  After 6 weeks of VNS treatment

Study Arms (3)

Vagus nerve stimulation

EXPERIMENTAL

Invasive vagus nerve stimulation

Diagnostic Test: Memory task

Transcutaneous vagus nerve stimulation

EXPERIMENTAL

Cymba concha stimulation

Diagnostic Test: Memory task

Sham vagus nerve stimulation

SHAM COMPARATOR

No vagus nerve stimulation

Diagnostic Test: Memory task

Interventions

Memory task DIAGNOSTIC_TEST

Word recognition task

Sham vagus nerve stimulation; Transcutaneous vagus nerve stimulation; Vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Refractory epilepsy
• Treated with vagus nerve stimulation
• IQ \>= 70 and able to perform the memory task

You may not qualify if:

• IQ \< 70

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital

Ghent, 9000, Belgium

Location

Related Publications (5)

• 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.

  PMID: 10195186 BACKGROUND

• 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.

  PMID: 25805212 BACKGROUND

• 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.

  PMID: 29326067 BACKGROUND

• 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.

  PMID: 25869158 BACKGROUND

• 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.

  PMID: 35132096 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 1, 2021
• Study Start: November 22, 2018
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

BE (1)