EpilepsyNCT02409069
Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task
A study testing Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH) in people with Epilepsy and Cognitive Decline, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The goal of this study is to investigate the influence of transcutaneous vagus nerve stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy volunteers. Preclinical and clinical studies indicate that noradrenaline plays a role in the working mechanism of vagus nerve stimulation. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Cognitive Decline
- What is being tested?
- Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Nov 2016to 14 Mar 2018
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between 18 and 30 years
- Bachelor, Master or PhD students
Who cannot join
- Neurological or psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to investigate the influence of transcutaneous vagus nerve stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy volunteers.
Preclinical and clinical studies indicate that noradrenaline plays a role in the working mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation.
Read more
The release of noradrenaline in the brain will be measured non-invasively by the P300 component of event-related potentials in the electro-encephalogram (EEG) via an auditory oddball paradigm.
Research to elucidate the working mechanism of non-invasive neurostimulation can help to identify subpopulations who will respond well to a treatment and can provide insights that could contribute to the optimalisation of the stimulation parameters, with as possible consequence a better clinical outcome.
Some studies indicate that stimulation of the vagus nerve can optimally influence memory, possibly via the noradrenergic system. This study will investigate if the effects of invasive vagus nerve stimulation on memory can be replicated with transcutaneous vagus nerve stimulation.
The influence of transcutaneous vagus nerve stimulation on memory will be measured via a neuropsychological memory task that investigates the ability to focus attention. The correlation between the performance on the memory task and the signal analysis of the auditory oddball task could give an indication about the underlying working mechanism of transcutaneous vagus nerve stimulation on memory.
This will be the first step to investigate whether transcutaneous vagus nerve stimulation can be used as innovative intervention for cognitive decline.
Read the detailed description
First a sympathetic skin response (SSR) will be measured to investigate whether the SSR could be used as a method to measure the activity of the locus coeruleus non-invasively.
There are 3 conditions:
- transcutaneous vagus nerve stimulation
- sham stimulation
- no stimulation
The conditions will be randomized.
In each condition the participant will do the oddball task and then the memory task. Between the conditions there is a wash-out period of 30 minutes. After completion of all 3 conditions and after a wash-out period of 30 minutes, the participant will do a final recognition task (part of the memory task in total).
During the oddball task EEG will be measured. An electro-cardiogram (ECG), electro-oculogram (EOG) and larynx electromyogram (EMG) will also be recorded for easy filtering of artefacts.
- Conditions
- Epilepsy, Cognitive Decline
- Being tested
- Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH), Sham stimulation (Nemos®, Cerbomed GmbH)
- Keywords
- Transcutaneous vagus nerve stimulation, P300, Memory task
- Medical subject headings
- Epilepsy, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)Device
Sham stimulation (Nemos®, Cerbomed GmbH)Device
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH) | Experimental | Stimulation of the ramus auricularis of the vagus nerve (ear) Receives: Device: Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH) |
| Sham stimulation (Nemos®, Cerbomed GmbH) | Sham comparator | Stimulation of the earlobe Receives: Device: Sham stimulation (Nemos®, Cerbomed GmbH) |
| No stimulation | No intervention | No stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of amplitude of P300 component of ERPs
Measured: 15 minutes
Performance on memory task as measured by number of correctly remembered words
Measured: 15 minutes
Secondary outcomes (2)
Analysis of latency of P300 component of ERPs
Measured: 15 minutes
Performance on memory task as measured by number of correctly recognized words
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study start3 Nov 2016
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neurologie, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409069
- Sponsor's protocol ID
- EC/2014/0249
- Status last verified
- Sep 2019
- First submitted
- 16 Mar 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task
- ClinicalTrials.gov ID
- NCT02409069
- Acronym / sponsor ID
- EC/2014/0249
- Conditions
- Epilepsy, Cognitive Decline
- Keywords
- Transcutaneous vagus nerve stimulation, P300, Memory task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 6 Apr 2015 (estimated)
- 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.
The goal of this study is to investigate the influence of transcutaneous vagus nerve stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy volunteers.
Preclinical and clinical studies indicate that noradrenaline plays a role in the working mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation.
The release of noradrenaline in the brain will be measured non-invasively by the P300 component of event-related potentials in the electro-encephalogram (EEG) via an auditory oddball paradigm.
Research to elucidate the working mechanism of non-invasive neurostimulation can help to identify subpopulations who will respond well to a treatment and can provide insights that could contribute to the optimalisation of the stimulation parameters, with as possible consequence a better clinical outcome.
Some studies indicate that stimulation of the vagus nerve can optimally influence memory, possibly via the noradrenergic system. This study will investigate if the effects of invasive vagus nerve stimulation on memory can be replicated with transcutaneous vagus nerve stimulation.
The influence of transcutaneous vagus nerve stimulation on memory will be measured via a neuropsychological memory task that investigates the ability to focus attention. The correlation between the performance on the memory task and the signal analysis of the auditory oddball task could give an indication about the underlying working mechanism of transcutaneous vagus nerve stimulation on memory.
This will be the first step to investigate whether transcutaneous vagus nerve stimulation can be used as innovative intervention for cognitive decline.
Detailed description
First a sympathetic skin response (SSR) will be measured to investigate whether the SSR could be used as a method to measure the activity of the locus coeruleus non-invasively.
There are 3 conditions:
- transcutaneous vagus nerve stimulation
- sham stimulation
- no stimulation
The conditions will be randomized.
In each condition the participant will do the oddball task and then the memory task. Between the conditions there is a wash-out period of 30 minutes. After completion of all 3 conditions and after a wash-out period of 30 minutes, the participant will do a final recognition task (part of the memory task in total).
During the oddball task EEG will be measured. An electro-cardiogram (ECG), electro-oculogram (EOG) and larynx electromyogram (EMG) will also be recorded for easy filtering of artefacts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH) | Experimental | Device: Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)Stimulation of the ramus auricularis of the vagus nerve (ear) |
| Sham stimulation (Nemos®, Cerbomed GmbH) | Sham comparator | Device: Sham stimulation (Nemos®, Cerbomed GmbH)Stimulation of the earlobe |
| No stimulation | No intervention | –No stimulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers between 18 and 30 years
- Bachelor, Master or PhD students
Key exclusion criteria (1 listed)
- Neurological or psychiatric disease
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 |
|---|---|---|
| Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH) | Device | Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH) |
| Sham stimulation (Nemos®, Cerbomed GmbH) | Device | Sham stimulation (Nemos®, Cerbomed GmbH) |
Primary outcome
Analysis of amplitude of P300 component of ERPs
Time frame: 15 minutes
Performance on memory task as measured by number of correctly remembered words
Time frame: 15 minutes
2 secondary outcomes
Analysis of latency of P300 component of ERPs
Time frame: 15 minutes
Performance on memory task as measured by number of correctly recognized words
Time frame: 15 minutes
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 25 Sep 2019.
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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 Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH) in people with Epilepsy and Cognitive Decline, 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 2 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 25 Sep 2019. 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?
Analysis of amplitude of P300 component of ERPs (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2019.