Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task
NCT ID: NCT02409069
Last Updated: 2019-09-25
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
NA
44 participants
INTERVENTIONAL
2016-11-03
2018-03-14
Brief Summary
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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.
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Detailed Description
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There are 3 conditions:
1. transcutaneous vagus nerve stimulation
2. sham stimulation
3. no stimulation
The conditions will be randomized.
In each condition the participant will do the oddball task and then the memory task. Between the conditions there is a wash-out period of 30 minutes. After completion of all 3 conditions and after a wash-out period of 30 minutes, the participant will do a final recognition task (part of the memory task in total).
During the oddball task EEG will be measured. An electro-cardiogram (ECG), electro-oculogram (EOG) and larynx electromyogram (EMG) will also be recorded for easy filtering of artefacts.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Study Groups
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Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Stimulation of the ramus auricularis of the vagus nerve (ear)
Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Sham stimulation (Nemos®, Cerbomed GmbH)
Stimulation of the earlobe
Sham stimulation (Nemos®, Cerbomed GmbH)
No stimulation
No stimulation
No interventions assigned to this group
Interventions
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Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Sham stimulation (Nemos®, Cerbomed GmbH)
Eligibility Criteria
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Inclusion Criteria
* Bachelor, Master or PhD students
Exclusion Criteria
18 Years
30 Years
ALL
Yes
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Neurologie
Prof. dr. Kristl Vonck
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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Other Identifiers
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EC/2014/0249
Identifier Type: -
Identifier Source: org_study_id
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