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Completed

NCT Number: NCT02359188

Transcutaneous Vagal Nerve Stimulation: Influence on miRNA, Inflammation, 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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Marburg, Hesse, 35043, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcutaneous vagal nerve stimulation

Device

4 hours of transcutaneous vagal nerve stimulation

Other names: NEMOS tVNS device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Differences in gastric motility between tVNS group and control group

    Time frame: After 4 hours of VNS

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • European Commission

Registry information

Official study title

Influence of Transcutaneous Vagal Nerve Stimulation on Expression of microRNA, Cytokines, Chemokines and Neuropeptides as Well as Cerebral Resting State and Gastric Motility

Acronym: EpimiRNA_D

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2015
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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