Refractory EpilepsyNCT05031208
Acute and Long Term Effects of VNS on Memory in Patients With Refractory Epilepsy
A study testing Memory task in people with Refractory Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Memory task
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Nov 2018to 28 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory epilepsy
- Treated with vagus nerve stimulation
- IQ >= 70 and able to perform the memory task
Who cannot join
- IQ < 70
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Refractory Epilepsy
- Being tested
- Memory task
- Keywords
- Vagus nerve stimulation, Transcutaneous vagus nerve stimulation, Word recognition paradigm
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory taskDiagnostic test
Word recognition task
| Study group | Role | What they receive |
|---|---|---|
| Vagus nerve stimulation | Experimental | Invasive vagus nerve stimulation Receives: Diagnostic Test: Memory task |
| Transcutaneous vagus nerve stimulation | Experimental | Cymba concha stimulation Receives: Diagnostic Test: Memory task |
| Sham vagus nerve stimulation | Sham comparator | No vagus nerve stimulation Receives: Diagnostic Test: Memory task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: After 6 weeks of VNS treatment
Secondary outcomes (2)
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
Measured: At baseline
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
Measured: After 6 weeks of VNS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start22 Nov 2018
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031208
- Sponsor's protocol ID
- EC/2016/0786
- Status last verified
- May 2023
- First submitted
- 19 Aug 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10195186Jacobs 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.
PubMed 25805212Colzato 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.
PubMed 29326067Steenbergen 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.
PubMed 25869158Mertens 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.
PubMed 35132096
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05031208
- Acronym / sponsor ID
- EC/2016/0786
- Conditions
- Refractory Epilepsy
- Keywords
- Vagus nerve stimulation, Transcutaneous vagus nerve stimulation, Word recognition paradigm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve stimulation | Experimental | Diagnostic Test: Memory taskInvasive vagus nerve stimulation |
| Transcutaneous vagus nerve stimulation | Experimental | Diagnostic Test: Memory taskCymba concha stimulation |
| Sham vagus nerve stimulation | Sham comparator | Diagnostic Test: Memory taskNo vagus nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Refractory epilepsy
- Treated with vagus nerve stimulation
- IQ >= 70 and able to perform the memory task
Key exclusion criteria (1 listed)
- IQ < 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory taskWord recognition task | Diagnostic test | Sham vagus nerve stimulation, Transcutaneous vagus nerve stimulation, Vagus nerve stimulation |
Primary outcome
Immediate recall score at session 1
Time frame: At baseline
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
Time frame: After 6 weeks of VNS treatment
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
Time frame: At baseline
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
Time frame: After 6 weeks of VNS treatment
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.
2 secondary outcomes
Attention score at session 1
Time frame: At baseline
Attention score at session 2
Time frame: After 6 weeks of VNS treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 10195186Clark 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.
- Background: PubMed 25805212Jacobs 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.
- Background: PubMed 29326067Colzato 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.
- Background: PubMed 25869158Steenbergen 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.
- Derived from this study: PubMed 35132096Mertens 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory task in people with Refractory Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate recall score at session 1 (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031208, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.