EpilepsyPhase 1/2EpimiRNA_DNCT02359188
Transcutaneous Vagal Nerve Stimulation: Influence on miRNA, Inflammation, Cerebral Resting State and Gastric Motility
A Phase 1/2 study testing Transcutaneous vagal nerve stimulation in people with Epilepsy, run by Philipps University Marburg at 1 site in Germany.
Trial summary
Randomized, double-blind trial to investigate the influence of a single 4 hours episode of transcutaneous vagal nerve stimulation on the expression of microRNA, various cytokines, chemokines, neuropeptides, cerebral resting state and gastric motility in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Transcutaneous vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Aug 2018
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Written informed consent
Who cannot join
- pregnancy
- active implants (like cardiac pacemaker, cochlea implant, implanted VNS)
- contraindications for MRI (e. g. metal fragments, claustrophobia)
- skin lesions in the ara of the left ear conch
- nickel allergy
- drug or alcohol abuse
- current acute disease or medical history of chronic disease
- participant is under legal guardianship
Trial locations and contacts
1 site in 1 country.
Germany1 site
Philipps-University Marburg, Dept. of Neurology, Epilepsy Center Hesse-Marburg
Marburg, Hesse, 35043
About this study
Official title: Influence of Transcutaneous Vagal Nerve Stimulation on Expression of microRNA, Cytokines, Chemokines and Neuropeptides as Well as Cerebral Resting State and Gastric Motility
Randomized, double-blind trial to investigate the influence of a single 4 hours episode of transcutaneous vagal nerve stimulation on the expression of microRNA, various cytokines, chemokines, neuropeptides, cerebral resting state and gastric motility in healthy volunteers.
Read the detailed description
Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive treatment option for epilepsy. TVNS works via electrical stimulation of the vagal nerve in the outer ear area via two steel electrodes and is performed for about 4 hours per day. Its mechanism of action is unknown. We hypothesize that expression of microRNA (miRNA), and/or release of cytokines, chemokines or neuropeptides is involved in the anticonvulsant activity. TVNS might also influence the cerebral resting state as measured by functional magnetic resonance imaging (fMRI). Due to it's anatomical connections, stimulation of the vagal nerve may furthermore result in altered gastric motility.
This study aims to detect levels of miRNA, cytokines, chemokines and neuropeptides in the blood of healthy volunteers before and after 4 hours of conventional tVNS or sham tVNS. Cerebral resting state and gastric motility will be measured by fMRI.
To this end, 60 healthy volunteers will be recruited and divided into 2 groups. 30 healthy volunteers will be treated with tVNS (25 Hz) for 4 hours (tVNS group). 30 healthy volunteers will be treated with sham tVNS (1 Hz) for 4 hours (control group).
On day 1 of the study, participants will be randomized to one of the two groups. Blood will be drawn from all participants at baseline. Both groups receive a standardized breakfast. TVNS ear electrodes will be put into place for 4 hours without electrical stimulation. Thereafter, blood will be drawn.
On day 2 of the study, blood will be drawn, and all participants receive a standardized breakfast again. Afterwards, tVNS (25 Hz) will be performed in participants of the tVNS group, and sham tVNS (1 Hz) will be performed in participants of the control group. TVNS or sham tVNS end after 4 hours. Blood will be drawn immediately after stimulation end. Thereafter, MRI will be performed in all participants (fMRT resting state, gastric motility). This ends the study for the participant.
- Conditions
- Epilepsy
- Being tested
- Transcutaneous vagal nerve stimulation
- Keywords
- Vagus Nerve Stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagal nerve stimulationDevice
Also called NEMOS tVNS device
4 hours of transcutaneous vagal nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| tVNS | Active comparator | Transcutaneous vagal nerve stimulation with 25 Hz Receives: Device: Transcutaneous vagal nerve stimulation |
| Sham-tVNS | Sham comparator | Sham transcutaneous vagal nerve stimulation with 1 Hz Receives: Device: Transcutaneous vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA expression profile in plasma of healthy persons before and after tVNS as compared to before and after sham tVNS
Measured: After 4 hours of VNS
Secondary outcomes (3)
Serum concentrations of different cytokines, chemokines and neuropeptides in healthy persons before and after tVNS as compared to before and after sham tVNS
Measured: After 4 hours of VNS
Differences in cerebral microstructural (DTI-MRI) and functional (resting state network, fMR) between tVNS group and control group
Measured: After 4 hours of VNS
Differences in gastric motility between tVNS group and control group
Measured: After 4 hours of VNS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startAug 2016
- Primary completionAug 2018
- Study completionAug 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.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Sebastian Bauer, Philipps University Marburg
- Investigators
- Sebastian Bauer, Dr., Principal investigator, Philipps-University Marburg, Dept. of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359188
- Sponsor's protocol ID
- KKS-207
- Acronym
- EpimiRNA_D
- Status last verified
- Sep 2018
- First submitted
- 4 Feb 2015
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Transcutaneous Vagal Nerve Stimulation on Expression of microRNA, Cytokines, Chemokines and Neuropeptides as Well as Cerebral Resting State and Gastric Motility
- ClinicalTrials.gov ID
- NCT02359188
- Acronym / sponsor ID
- EpimiRNA_D / KKS-207
- Conditions
- Epilepsy
- Keywords
- Vagus Nerve Stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 9 Feb 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.
Randomized, double-blind trial to investigate the influence of a single 4 hours episode of transcutaneous vagal nerve stimulation on the expression of microRNA, various cytokines, chemokines, neuropeptides, cerebral resting state and gastric motility in healthy volunteers.
Detailed description
Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive treatment option for epilepsy. TVNS works via electrical stimulation of the vagal nerve in the outer ear area via two steel electrodes and is performed for about 4 hours per day. Its mechanism of action is unknown. We hypothesize that expression of microRNA (miRNA), and/or release of cytokines, chemokines or neuropeptides is involved in the anticonvulsant activity. TVNS might also influence the cerebral resting state as measured by functional magnetic resonance imaging (fMRI). Due to it's anatomical connections, stimulation of the vagal nerve may furthermore result in altered gastric motility.
This study aims to detect levels of miRNA, cytokines, chemokines and neuropeptides in the blood of healthy volunteers before and after 4 hours of conventional tVNS or sham tVNS. Cerebral resting state and gastric motility will be measured by fMRI.
To this end, 60 healthy volunteers will be recruited and divided into 2 groups. 30 healthy volunteers will be treated with tVNS (25 Hz) for 4 hours (tVNS group). 30 healthy volunteers will be treated with sham tVNS (1 Hz) for 4 hours (control group).
On day 1 of the study, participants will be randomized to one of the two groups. Blood will be drawn from all participants at baseline. Both groups receive a standardized breakfast. TVNS ear electrodes will be put into place for 4 hours without electrical stimulation. Thereafter, blood will be drawn.
On day 2 of the study, blood will be drawn, and all participants receive a standardized breakfast again. Afterwards, tVNS (25 Hz) will be performed in participants of the tVNS group, and sham tVNS (1 Hz) will be performed in participants of the control group. TVNS or sham tVNS end after 4 hours. Blood will be drawn immediately after stimulation end. Thereafter, MRI will be performed in all participants (fMRT resting state, gastric motility). This ends the study for the participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tVNS | Active comparator | Device: Transcutaneous vagal nerve stimulationTranscutaneous vagal nerve stimulation with 25 Hz |
| Sham-tVNS | Sham comparator | Device: Transcutaneous vagal nerve stimulationSham transcutaneous vagal nerve stimulation with 1 Hz |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 65 years
- Written informed consent
Key exclusion criteria (8 listed)
- pregnancy
- active implants (like cardiac pacemaker, cochlea implant, implanted VNS)
- contraindications for MRI (e. g. metal fragments, claustrophobia)
- skin lesions in the ara of the left ear conch
- nickel allergy
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 vagal nerve stimulationAlso: NEMOS tVNS device4 hours of transcutaneous vagal nerve stimulation | Device | Sham-tVNS, tVNS |
Primary outcome
miRNA expression profile in plasma of healthy persons before and after tVNS as compared to before and after sham tVNS
Time frame: After 4 hours of VNS
3 secondary outcomes
Serum concentrations of different cytokines, chemokines and neuropeptides in healthy persons before and after tVNS as compared to before and after sham tVNS
Time frame: After 4 hours of VNS
Differences in cerebral microstructural (DTI-MRI) and functional (resting state network, fMR) between tVNS group and control group
Time frame: After 4 hours of VNS
Differences in gastric motility between tVNS group and control group
Time frame: After 4 hours of VNS
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 13 Sep 2018.
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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.
Sebastian Bauer, Dr. principal investigator
Philipps-University Marburg, Dept. of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcutaneous vagal nerve stimulation in people with Epilepsy, run by Philipps University Marburg at 1 site in Germany.
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 8 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 13 Sep 2018. 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 Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
miRNA expression profile in plasma of healthy persons before and after tVNS as compared to before and after sham tVNS (time frame: After 4 hours of VNS). 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 13 Sep 2018.