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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

Primary Purpose

Epilepsy, Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Sham stimulation (Nemos®, Cerbomed GmbH)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy focused on measuring Transcutaneous vagus nerve stimulation, P300, Memory task

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurological or psychiatric disease

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)

Sham stimulation (Nemos®, Cerbomed GmbH)

No stimulation

Arm Description

Stimulation of the ramus auricularis of the vagus nerve (ear)

Stimulation of the earlobe

No stimulation

Outcomes

Primary Outcome Measures

Analysis of amplitude of P300 component of ERPs
Performance on memory task as measured by number of correctly remembered words

Secondary Outcome Measures

Analysis of latency of P300 component of ERPs
Performance on memory task as measured by number of correctly recognized words

Full Information

First Posted
March 16, 2015
Last Updated
September 24, 2019
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT02409069
Brief Title
Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
March 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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: transcutaneous vagus nerve stimulation sham stimulation 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Cognitive Decline
Keywords
Transcutaneous vagus nerve stimulation, P300, Memory task

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Arm Type
Experimental
Arm Description
Stimulation of the ramus auricularis of the vagus nerve (ear)
Arm Title
Sham stimulation (Nemos®, Cerbomed GmbH)
Arm Type
Sham Comparator
Arm Description
Stimulation of the earlobe
Arm Title
No stimulation
Arm Type
No Intervention
Arm Description
No stimulation
Intervention Type
Device
Intervention Name(s)
Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)
Intervention Type
Device
Intervention Name(s)
Sham stimulation (Nemos®, Cerbomed GmbH)
Primary Outcome Measure Information:
Title
Analysis of amplitude of P300 component of ERPs
Time Frame
15 minutes
Title
Performance on memory task as measured by number of correctly remembered words
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Analysis of latency of P300 component of ERPs
Time Frame
15 minutes
Title
Performance on memory task as measured by number of correctly recognized words
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers between 18 and 30 years Bachelor, Master or PhD students Exclusion Criteria: Neurological or psychiatric disease
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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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

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