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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Refractory Epilepsy

Treatments

Diagnostic Test: Memory task

Study type

Interventional

Funder types

Other

Identifiers

NCT05031208
EC/2016/0786

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • IQ < 70

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

16 participants in 3 patient groups

Vagus nerve stimulation
Experimental group
Description:
Invasive vagus nerve stimulation
Treatment:
Diagnostic Test: Memory task
Transcutaneous vagus nerve stimulation
Experimental group
Description:
Cymba concha stimulation
Treatment:
Diagnostic Test: Memory task
Sham vagus nerve stimulation
Sham Comparator group
Description:
No vagus nerve stimulation
Treatment:
Diagnostic Test: Memory task

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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