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Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task

NCT02409069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-09-25

No results posted yet for this study

Summary

The goal of this study is to investigate the influence of transcutaneous vagus nerve stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy volunteers.

Preclinical and clinical studies indicate that noradrenaline plays a role in the working mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation.

The release of noradrenaline in the brain will be measured non-invasively by the P300 component of event-related potentials in the electro-encephalogram (EEG) via an auditory oddball paradigm.

Research to elucidate the working mechanism of non-invasive neurostimulation can help to identify subpopulations who will respond well to a treatment and can provide insights that could contribute to the optimalisation of the stimulation parameters, with as possible consequence a better clinical outcome.

Some studies indicate that stimulation of the vagus nerve can optimally influence memory, possibly via the noradrenergic system. This study will investigate if the effects of invasive vagus nerve stimulation on memory can be replicated with transcutaneous vagus nerve stimulation.

The influence of transcutaneous vagus nerve stimulation on memory will be measured via a neuropsychological memory task that investigates the ability to focus attention. The correlation between the performance on the memory task and the signal analysis of the auditory oddball task could give an indication about the underlying working mechanism of transcutaneous vagus nerve stimulation on memory.

This will be the first step to investigate whether transcutaneous vagus nerve stimulation can be used as innovative intervention for cognitive decline.

Conditions

Interventions

DEVICE

Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)

DEVICE

Sham stimulation (Nemos®, Cerbomed GmbH)

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2018-03-14
Completion
2018-03-14

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02409069 on ClinicalTrials.gov