Transcutaneous Vagal Nerve Stimulation: Influence on miRNA, Inflammation, Cerebral Resting State and Gastric Motility
EpimiRNA_D
Influence of Transcutaneous Vagal Nerve Stimulation on Expression of microRNA, Cytokines, Chemokines and Neuropeptides as Well as Cerebral Resting State and Gastric Motility
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 9, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 13, 2018
September 1, 2018
2 years
February 4, 2015
September 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
miRNA expression profile in plasma of healthy persons before and after tVNS as compared to before and after sham tVNS
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
After 4 hours of VNS
Differences in cerebral microstructural (DTI-MRI) and functional (resting state network, fMR) between tVNS group and control group
After 4 hours of VNS
Differences in gastric motility between tVNS group and control group
After 4 hours of VNS
Study Arms (2)
tVNS
ACTIVE COMPARATORTranscutaneous vagal nerve stimulation with 25 Hz
Sham-tVNS
SHAM COMPARATORSham transcutaneous vagal nerve stimulation with 1 Hz
Interventions
4 hours of transcutaneous vagal nerve stimulation
Eligibility Criteria
You may qualify if:
- Age between 18 and 65 years
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philipps University Marburglead
- European Commissioncollaborator
Study Sites (1)
Philipps-University Marburg, Dept. of Neurology, Epilepsy Center Hesse-Marburg
Marburg, Hesse, 35043, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Bauer, Dr.
Philipps-University Marburg, Dept. of Neurology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 4, 2015
First Posted
February 9, 2015
Study Start
August 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
September 13, 2018
Record last verified: 2018-09