Autonomic Nervous SystemMSNANCT04057508
Non-invasive Modulation of Autonomic Cardiac Nervous System
A study testing Modulation of muscle sympathetic nerve activity in people with Autonomic Nervous System and Heart Rate Variability, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To demonstrate the effect of non invasive vagus nerve (VNS) stimulation on heart rate variability and MSNA signal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System, Heart Rate Variability, Muscle Sympathetic Nerve Activity
- What is being tested?
- Modulation of muscle sympathetic nerve activity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jun 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- >18 years old
Who cannot join
- pregnancy and breastfeeding
- smoke
- alcool/energy drinks/coffee consumption, exertion 24h before the participation
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Erasme University Hospital
Brussels, 1070
Anaïs Gauthey, MD, 025555919 ext. 0032, anais.gauthey@uclouvain.be
SRB Service de Recherche Biomédicale, 02 25 55 83 51 ext. 0032, Service.Rech-biomed@erasme.ulb.ac.be
About this study
Official title: Effects of Non Invasive Vagus Nerve Stimulation on Heart Rate Variability in Healthy Subjects and on Muscle Sympathetic Nerve Activity
To demonstrate the effect of non invasive vagus nerve (VNS) stimulation on heart rate variability and MSNA signal.
Read the detailed description
First part: Assessment of the muscle sympathetic nerve activity (MSNA) at baseline using microneurography performed on the superficial peroneal nerve.
Second part: Acquisition of the MSNA signal during non-invasive VNS and apnea. Non-invasive VNS is performed using several frequencies of stimulation. Maximal and voluntaries apnea are performed at the end of the expiration.
Continuous recording of the following parameters:
- non-invasive arterial blood pressure
- R-R interval
- electrocardiogram
- MSNA activity
- respiratory curve signal
- respiratory rate, oxygen saturation
- Being tested
- Modulation of muscle sympathetic nerve activity
- Keywords
- Heart rate variability, MSNA, vagus nerve, sympathetic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modulation of muscle sympathetic nerve activityOther
Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation protocol | Active comparator | Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order . Receives: Other: Modulation of muscle sympathetic nerve activity |
| Sham stimulation protocol | Sham comparator | Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order. Receives: Other: Modulation of muscle sympathetic nerve activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability modulation
Modulation of heart rate variability assessed through analysis of MSNA signal
Measured: 4 hours
Secondary outcomes (2)
Non-invasive vagus nerve stimulation
Modulation of parasympathetic tone based on two different frequencies stimulation
Measured: 4hours
Profile of response for MSNA
To describe positive and negative patterns of MSNA response
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start19 Jun 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous SystemStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized, controlled, double-blind, cross-over study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Erasme University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057508
- Sponsor's protocol ID
- TFE_201904_097
- Acronym
- MSNA
- Status last verified
- Jul 2019
- First submitted
- 13 Aug 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non Invasive Vagus Nerve Stimulation on Heart Rate Variability in Healthy Subjects and on Muscle Sympathetic Nerve Activity
- ClinicalTrials.gov ID
- NCT04057508
- Acronym / sponsor ID
- MSNA / TFE_201904_097
- Keywords
- Heart rate variability, MSNA, vagus nerve, sympathetic nervous system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Erasme University Hospital
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the effect of non invasive vagus nerve (VNS) stimulation on heart rate variability and MSNA signal.
Detailed description
First part: Assessment of the muscle sympathetic nerve activity (MSNA) at baseline using microneurography performed on the superficial peroneal nerve.
Second part: Acquisition of the MSNA signal during non-invasive VNS and apnea. Non-invasive VNS is performed using several frequencies of stimulation. Maximal and voluntaries apnea are performed at the end of the expiration.
Continuous recording of the following parameters:
- non-invasive arterial blood pressure
- R-R interval
- electrocardiogram
- MSNA activity
- respiratory curve signal
- respiratory rate, oxygen saturation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blind, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Stimulation protocol | Active comparator | Other: Modulation of muscle sympathetic nerve activityEach subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order . |
| Sham stimulation protocol | Sham comparator | Other: Modulation of muscle sympathetic nerve activityEach subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- >18 years old
Key exclusion criteria (3 listed)
- pregnancy and breastfeeding
- smoke
- alcool/energy drinks/coffee consumption, exertion 24h before the participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modulation of muscle sympathetic nerve activityAssessment of muscle sympathetic nerve signal and exposition to external non invasive modulation. | Other | Sham stimulation protocol, Stimulation protocol |
Primary outcome
Heart rate variability modulation
Time frame: 4 hours
Modulation of heart rate variability assessed through analysis of MSNA signal
2 secondary outcomes
Non-invasive vagus nerve stimulation
Time frame: 4hours
Profile of response for MSNA
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modulation of muscle sympathetic nerve activity in people with Autonomic Nervous System and Heart Rate Variability, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anaïs Gauthey, MD (027682888 ext. 0032, anais.gauthey@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability modulation (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.