Transcutaneous Vagal Nerve Stimulation: Influence on miRNA, Inflammation, Cerebral Resting State and Gastric Motility (EpimiRNA_D)

September 12, 2018 updated by: Sebastian Bauer, Philipps University Marburg Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Philipps-University Marburg, Dept. of Neurology, Epilepsy Center Hesse-Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Written informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: tVNS
Transcutaneous vagal nerve stimulation with 25 Hz
Device: Transcutaneous vagal nerve stimulation
4 hours of transcutaneous vagal nerve stimulation
Other Names:
  • NEMOS tVNS device
SHAM_COMPARATOR: Sham-tVNS
Sham transcutaneous vagal nerve stimulation with 1 Hz
Device: Transcutaneous vagal nerve stimulation
4 hours of transcutaneous vagal nerve stimulation
Other Names:
  • NEMOS tVNS device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After 4 hours of VNS

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
After 4 hours of VNS
Differences in gastric motility between tVNS group and control group
Time Frame: After 4 hours of VNS
After 4 hours of VNS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Collaborators

European Commission

Investigators

  • Principal Investigator: Sebastian Bauer, Dr., Philipps-University Marburg, Dept. of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (ESTIMATE)

February 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKS-207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on Transcutaneous vagal nerve stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe