Vagus Nerve DiseasesNCT04192877
Validity and Inter-rater Reliability fo the Vagus Nerve Neurodynamic Test Among Healthy Subjects
An observational study of Vagus Nerve Diseases and Diagnoses Disease, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Vagus nerve neurodynamic test (VN-NDT) will be validated detecting the changes in vagus nerve anatomical position due to the combination of movements of the test. Healthy subjects will be enrolled and screened for neurological problems. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vagus Nerve Diseases, Diagnoses Disease
- What is being tested?
- Vagus Nerve Neurodynamic test
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2019to 16 Dec 2019
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects that want to participate in the study
Who may be able to join
- Subjects aged between 18 and 70 years old
- Subjects that have signed the written informed consent
Who cannot join
- Subjects with significant neck pain or headache (with NRS greater than 3/10)
- Pregnancy
- Recent neck surgery or significant trauma in the preceding 3 months
- Cancer or inflammatory disorders spinal cord or cauda equina signs
- Widespread neurological disorders affecting the tone of upper limb and neck muscles
- Underlying diseases, such as diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Inter-rater Reliability of the Vagus Nerve Neurodynamic Test Among Healthy Subjects.
Vagus nerve neurodynamic test (VN-NDT) will be validated detecting the changes in vagus nerve anatomical position due to the combination of movements of the test. Healthy subjects will be enrolled and screened for neurological problems. A checklist for autonomic dysfuntion symptoms will be administered and heart rate at rest will be measured. Inter-rater reliability will be assessed comparing positive and negative cases identified by two blinded assessors, one expert and one novice. It will also be monitored and compared the amount of motion induced by the expert and the novice assessors during the VN-NDT admimistration. If symptoms will be produced by the VN-NDT using a pain drawing tool it will be defined the qualitiy and the location of them. Accuracy of the VN-NDT will be tested in the autonomic dysfunction symptom detection.
Read the detailed description
_A growing body of evidence has shown that the Vagus Nerve (VN) is not only the main anatomical structure responsible for the brain and guts communication but is also a target for many interventions in which drugs or classic treatments have failed. The VN cervical tract stimulation has reported positive results for high social burden problems like acute and chronic pain, psychiatric diseases, disturbs of consciousness and epilepsy. Also, it is well known that the selective tension of the Peripheral Nervous System, or neurodynamic test (NDT), is useful for diagnosis and treatment of neuropathic diseases and pain. Over the last 30 years NDTs were validated for upper and lower limb nerves but nowadays a VN-NDT is lacking and could be a potential alternative in diagnosis and treatment for critical or neglected conditions. Methods_ An estimated sample of 30 healthy participants will complete a questionnaire on vagal symptoms and perceived health status. A neurological assessment of the cervical tract will be performed before the test. The VN-NDT will be administered through a standardized sequence of physiological neck movements. Symptoms and heart rate (HR) will be monitored. Validity of NDT will be tested with ultrasonography assessment (C6-VN distance) during the tests administered by an expert and a novice. Motion of both assessors and subjects will be tracked through an infra-red optoelectronic system. Inter-examiner accordance will be obtained and comparisons between assessors' positive and negative tests due to symptoms provocation and reduction (Cohen's Kappa) will be performed. A two-way analysis of variance (ANOVA) will be performed with factors experience and side tested (2 × 2). Receiver operating characteristic (ROC) curves will be adopted to define the accuracy, sensitivity, specificity, positive and negative likelihood ratios of the VN-NDT in autonomic dysfunction symptoms detection and on perceived health status.Results_ It is expected to determine the inter-examiner accordance and to not detect significant assessors effects on test results. It is also expected to detect a change of the C6-VN distance and HR during the test and to estimate the accuracy of the test for autonomic dysfunctions detection.Conclusions_ Normative physiological values parameter variations at the administration of the VN-NDT are fundamental to determine the hallmarks needed to screen clinical and preclinical conditions involving autonomic dysfunctions_
- Conditions
- Vagus Nerve Diseases, Diagnoses Disease
- Being tested
- Vagus Nerve Neurodynamic test
- Keywords
- Validation Studies, Vagus Nerve Diseases, Diagnostic imaging, Motion analysis, Healthy Volunteers
- Medical subject headings
- Vagus Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Neurodynamic testDiagnostic test
Also called Heart rate monitoring using a digital pulsossimeter
The VN-NDT has been developed starting from the VN morphology selecting the physiological movements that induce the greater mechanical tension on the nerve. The subjects will be assessed supine on an examination table with assessors standing at the cranial short side of the table. Upper cervical flexion and contralateral lateral flexion had been selected for loading the intracranial portion. The ipsilateral neck rotation had been selected for loading the cervical tract. Keeping the subject's head in the final movements combination gentle movements of the upper abdomen caudally and cranially had been selected for loading the thoracic tract and used as discrimination maneuver. The test will be declared positive (indicating abnormal responses) if symptoms will be felt in anatomical regions other than the neck on the same side of the test and discrimination maneuvers changed the subject's symptoms indicating a neurogenic source, otherwise it will be declared negative.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 30 healthy subjects from both genders, aged between 18 and 60 years will be screened for neurological deficits. If neurological examination will be negative markers for motion capture, analysis will be placed on the chest and shoulders and a rubber band, with 3 markers, will be placed on the forehead. The subjects will be invited to lay on a medical table and heart rate (HR) will be assessed at rest. The vagus nerve neurodynamic test (VN-NDT) will be performed by an expert and a novice, in a random order, and under ultrasound imaging (USI). Assessors will be blinded to their results. Heart rate (HR) of the subjects will be monitored and a pain drawaing tools will be used to describe and locate the symptoms induced during the test administration. Receives: Diagnostic Test: Vagus Nerve Neurodynamic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vagus nerve neurodynamic test (VN-NDT)
combination of physiological movements of the neck (upper cervical flexion, contralateral lateral flexion, ipsilteral rotation and gentle movements of the upper abdomen caudally and cranially to increase tension on the thoracic tract of the VN)
Measured: The test will be administered twice for each side, once by an expert and once by a novice.
Ultrasound imaging (USI)
Axial scans will be obtained using the inferior margin of the thyroid as initial reference from which the probe will be moved laterally to the region of the transverse processes. The probe will also be moved cranially till anterior tubercle of C6 detection. Distance between VN and C6 anterior tubercle will be measured at rest and at the final position of the VN-NDT to quantify the lateralization or proximalization of the VN induced by the test.
Measured: USI will be administered twice for each side, once by an expert and once by a novice.
Motion capture analysis (MCA)
Throughout the whole duration of VN-NDT with real-time USI assessment, the three-dimensional head orientation of the subjects will be recorded at 100 Hz by means of an optoelectronic motion capture system (Smart-DX, BTS S.p.A., Milano, Italy). A cluster with three retroreflective markers (diameter: 15 mm) will be secured on the subject's head using an elastic band; three additional markers will be fixed on the acromia and on the sternum. The time event corresponding to the obtainment of a proper USI in the rest and final head positions will be manually annotated upon explicit communication by the USI operator.System calibration will be conducted according to the manufacturers' guidelines and returned an average error in marker position of 0.35 mm, on a working volume of 2.6 x 1.8 x 2.5 m3
Measured: MCA will be used for the duration the VN-NDT administered twice for each side, once by an expert and once by a novice.
Short-term autonomic response (STAR)
The heart rate will be taken (HR) as reference comparing the HR from rest to the HR keeping the head and neck of the subjects in the end position of the VN-NDT for 5 seconds
Measured: HR will be measured at rest and end of the VN-NDT for each sides (4 times by an expert and 4 times by a novice).
Secondary outcomes (2)
Checklist for symptoms related to autonomic peripheral neuropathy (APN) and VN dysfunction
A checklist for the presence of any symptoms and signs reported in literature to be linked with APN and VN diseases was fulfilled by every participant (Orthostatic Hypotension; Nausea; Digestion Alterations; Breathing Alterations (shortness of breath); Voice Changes; Altered deglutition; Perceived augmented HR;Perceived reduced HR; Burning sensation in the stomach; Constipation; Diarrheal; Vomit; Augmented lacrimation; Reduced lacrimation; Augmented salivation; Reduced salivation; Head and neck sweating attacks; Head and neck skin dryness; Sleep alteration)
Measured: The checklist will be administred once. Before the neurological examination
Perceived health status (PHS)
A 11 point Likert scale was administered to assess the Perceived health status (100 the best 0 the worst health status ever)
Measured: The PHS will be administred once. Before the neurological examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start5 Dec 2019
- Primary completion12 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano
- Responsible party
- Principal investigator, Giacomo Carta, University of Turin, Italy
- Investigators
- Giacomo Carta, Msc, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192877
- Sponsor's protocol ID
- 139870-14/03/2019
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available. All of the individual particiapnt data collected during the trial will be shared after deidentification
Publications
Carta G, Seregni A, Casamassima A, Galli M, Geuna S, Pagliaro P, Zago M. Validation and Reliability of a Novel Vagus Nerve Neurodynamic Test and Its Effects on Heart Rate in Healthy Subjects: Little Differences Between Sexes. Front Neurosci. 2021 Sep 6;15:698470. doi: 10.3389/fnins.2021.698470. eCollection 2021.
PubMed 34552462
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Inter-rater Reliability of the Vagus Nerve Neurodynamic Test Among Healthy Subjects.
- ClinicalTrials.gov ID
- NCT04192877
- Acronym / sponsor ID
- 139870-14/03/2019
- Conditions
- Vagus Nerve Diseases, Diagnoses Disease
- Keywords
- Validation Studies, Vagus Nerve Diseases, Diagnostic imaging, Motion analysis, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Politecnico di Milano
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 10 Dec 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.
Vagus nerve neurodynamic test (VN-NDT) will be validated detecting the changes in vagus nerve anatomical position due to the combination of movements of the test. Healthy subjects will be enrolled and screened for neurological problems. A checklist for autonomic dysfuntion symptoms will be administered and heart rate at rest will be measured. Inter-rater reliability will be assessed comparing positive and negative cases identified by two blinded assessors, one expert and one novice. It will also be monitored and compared the amount of motion induced by the expert and the novice assessors during the VN-NDT admimistration. If symptoms will be produced by the VN-NDT using a pain drawing tool it will be defined the qualitiy and the location of them. Accuracy of the VN-NDT will be tested in the autonomic dysfunction symptom detection.
Detailed description
_A growing body of evidence has shown that the Vagus Nerve (VN) is not only the main anatomical structure responsible for the brain and guts communication but is also a target for many interventions in which drugs or classic treatments have failed. The VN cervical tract stimulation has reported positive results for high social burden problems like acute and chronic pain, psychiatric diseases, disturbs of consciousness and epilepsy. Also, it is well known that the selective tension of the Peripheral Nervous System, or neurodynamic test (NDT), is useful for diagnosis and treatment of neuropathic diseases and pain. Over the last 30 years NDTs were validated for upper and lower limb nerves but nowadays a VN-NDT is lacking and could be a potential alternative in diagnosis and treatment for critical or neglected conditions. Methods_ An estimated sample of 30 healthy participants will complete a questionnaire on vagal symptoms and perceived health status. A neurological assessment of the cervical tract will be performed before the test. The VN-NDT will be administered through a standardized sequence of physiological neck movements. Symptoms and heart rate (HR) will be monitored. Validity of NDT will be tested with ultrasonography assessment (C6-VN distance) during the tests administered by an expert and a novice. Motion of both assessors and subjects will be tracked through an infra-red optoelectronic system. Inter-examiner accordance will be obtained and comparisons between assessors' positive and negative tests due to symptoms provocation and reduction (Cohen's Kappa) will be performed. A two-way analysis of variance (ANOVA) will be performed with factors experience and side tested (2 × 2). Receiver operating characteristic (ROC) curves will be adopted to define the accuracy, sensitivity, specificity, positive and negative likelihood ratios of the VN-NDT in autonomic dysfunction symptoms detection and on perceived health status.Results_ It is expected to determine the inter-examiner accordance and to not detect significant assessors effects on test results. It is also expected to detect a change of the C6-VN distance and HR during the test and to estimate the accuracy of the test for autonomic dysfunctions detection.Conclusions_ Normative physiological values parameter variations at the administration of the VN-NDT are fundamental to determine the hallmarks needed to screen clinical and preclinical conditions involving autonomic dysfunctions_
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Diagnostic Test: Vagus Nerve Neurodynamic test30 healthy subjects from both genders, aged between 18 and 60 years will be screened for neurological deficits. If neurological examination will be negative markers for motion capture, analysis will be placed on the chest and shoulders and a rubber band, with 3 markers, will be placed on the forehead. The subjects will be invited to lay on a medical table and heart rate (HR) will be assessed at rest. The vagus nerve neurodynamic test (VN-NDT) will be performed by an expert and a novice, in a random order, and under ultrasound imaging (USI). Assessors will be blinded to their results. Heart rate (HR) of the subjects will be monitored and a pain drawaing tools will be used to describe and locate the symptoms induced during the test administration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects that want to participate in the study
Key inclusion criteria (2 listed)
- Subjects aged between 18 and 70 years old
- Subjects that have signed the written informed consent
Key exclusion criteria (6 listed)
- Subjects with significant neck pain or headache (with NRS greater than 3/10)
- Pregnancy
- Recent neck surgery or significant trauma in the preceding 3 months
- Cancer or inflammatory disorders spinal cord or cauda equina signs
- Widespread neurological disorders affecting the tone of upper limb and neck muscles
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 |
|---|---|---|
| Vagus Nerve Neurodynamic testAlso: Heart rate monitoring using a digital pulsossimeterThe VN-NDT has been developed starting from the VN morphology selecting the physiological movements that induce the greater mechanical tension on the nerve. The subjects will be assessed supine on an examination table with assessors standing at the cranial short side of the table. Upper cervical flexion and contralateral lateral flexion had been selected for loading the intracranial portion. The ipsilateral neck rotation had been selected for loading the cervical tract. Keeping the subject's head in the final movements combination gentle movements of the upper abdomen caudally and cranially had been selected for loading the thoracic tract and used as discrimination maneuver. The test will be declared positive (indicating abnormal responses) if symptoms will be felt in anatomical regions other than the neck on the same side of the test and discrimination maneuvers changed the subject's symptoms indicating a neurogenic source, otherwise it will be declared negative. | Diagnostic test | Experimental |
Primary outcome
Vagus nerve neurodynamic test (VN-NDT)
Time frame: The test will be administered twice for each side, once by an expert and once by a novice.
combination of physiological movements of the neck (upper cervical flexion, contralateral lateral flexion, ipsilteral rotation and gentle movements of the upper abdomen caudally and cranially to increase tension on the thoracic tract of the VN)
Ultrasound imaging (USI)
Time frame: USI will be administered twice for each side, once by an expert and once by a novice.
Axial scans will be obtained using the inferior margin of the thyroid as initial reference from which the probe will be moved laterally to the region of the transverse processes. The probe will also be moved cranially till anterior tubercle of C6 detection. Distance between VN and C6 anterior tubercle will be measured at rest and at the final position of the VN-NDT to quantify the lateralization or proximalization of the VN induced by the test.
Motion capture analysis (MCA)
Time frame: MCA will be used for the duration the VN-NDT administered twice for each side, once by an expert and once by a novice.
Throughout the whole duration of VN-NDT with real-time USI assessment, the three-dimensional head orientation of the subjects will be recorded at 100 Hz by means of an optoelectronic motion capture system (Smart-DX, BTS S.p.A., Milano, Italy). A cluster with three retroreflective markers (diameter: 15 mm) will be secured on the subject's head using an elastic band; three additional markers will be fixed on the acromia and on the sternum. The time event corresponding to the obtainment of a proper USI in the rest and final head positions will be manually annotated upon explicit communication by the USI operator.System calibration will be conducted according to the manufacturers' guidelines and returned an average error in marker position of 0.35 mm, on a working volume of 2.6 x 1.8 x 2.5 m3
Short-term autonomic response (STAR)
Time frame: HR will be measured at rest and end of the VN-NDT for each sides (4 times by an expert and 4 times by a novice).
The heart rate will be taken (HR) as reference comparing the HR from rest to the HR keeping the head and neck of the subjects in the end position of the VN-NDT for 5 seconds
2 secondary outcomes
Checklist for symptoms related to autonomic peripheral neuropathy (APN) and VN dysfunction
Time frame: The checklist will be administred once. Before the neurological examination
Perceived health status (PHS)
Time frame: The PHS will be administred once. Before the neurological examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Derived from this study: PubMed 34552462Carta G, Seregni A, Casamassima A, Galli M, Geuna S, Pagliaro P, Zago M. Validation and Reliability of a Novel Vagus Nerve Neurodynamic Test and Its Effects on Heart Rate in Healthy Subjects: Little Differences Between Sexes. Front Neurosci. 2021 Sep 6;15:698470. doi: 10.3389/fnins.2021.698470. eCollection 2021.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available. All of the individual particiapnt data collected during the trial will be shared after deidentification
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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.
Giacomo Carta, Msc principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vagus Nerve Diseases and Diagnoses Disease, run by University of Turin, Italy at 1 site in Italy.
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 6 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: finished, as of the sponsor's last update on 17 Dec 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 Italy. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vagus nerve neurodynamic test (VN-NDT) (time frame: The test will be administered twice for each side, once by an expert and once by a novice.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192877, which also lists 1 linked publication.
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 17 Dec 2019.