Transcutaneous Vagal Nerve Stimulation: Influence on miRNA, Inflammation, Cerebral Resting State and Gastric Motility
NCT ID: NCT02359188
Last Updated: 2018-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2016-08-31
2018-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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tVNS
Transcutaneous vagal nerve stimulation with 25 Hz
Transcutaneous vagal nerve stimulation
4 hours of transcutaneous vagal nerve stimulation
Sham-tVNS
Sham transcutaneous vagal nerve stimulation with 1 Hz
Transcutaneous vagal nerve stimulation
4 hours of transcutaneous vagal nerve stimulation
Interventions
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Transcutaneous vagal nerve stimulation
4 hours of transcutaneous vagal nerve stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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European Commission
OTHER
Philipps University Marburg
OTHER
Responsible Party
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Sebastian Bauer
Dr.
Principal Investigators
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Sebastian Bauer, Dr.
Role: PRINCIPAL_INVESTIGATOR
Philipps-University Marburg, Dept. of Neurology
Locations
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Philipps-University Marburg, Dept. of Neurology, Epilepsy Center Hesse-Marburg
Marburg, Hesse, Germany
Countries
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Other Identifiers
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KKS-207
Identifier Type: -
Identifier Source: org_study_id
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