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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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Epilepsy
Cognitive Decline

Treatments

Device: Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Device: Sham stimulation (Nemos®, Cerbomed GmbH)

Study type

Interventional

Funder types

Other

Identifiers

NCT02409069
EC/2014/0249

Details and patient eligibility

About

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.

Full description

First a sympathetic skin response (SSR) will be measured to investigate whether the SSR could be used as a method to measure the activity of the locus coeruleus non-invasively.

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.

Enrollment

44 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy volunteers between 18 and 30 years
  • Bachelor, Master or PhD students

Exclusion criteria

  • Neurological or psychiatric disease

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

44 participants in 3 patient groups

Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Experimental group
Description:
Stimulation of the ramus auricularis of the vagus nerve (ear)
Treatment:
Device: Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Sham stimulation (Nemos®, Cerbomed GmbH)
Sham Comparator group
Description:
Stimulation of the earlobe
Treatment:
Device: Sham stimulation (Nemos®, Cerbomed GmbH)
No stimulation
No Intervention group
Description:
No stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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