Validity and Inter-rater Reliability fo the Vagus Nerve Neurodynamic Test Among Healthy Subjects

NCT04192877 | Completed

• 1 other identifier: 139870-14/03/2019
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vagus Nerve Diseases; Diagnoses Disease

Keywords

Validation Studies; Vagus Nerve Diseases; Diagnostic imaging; Motion analysis; Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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)

  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.

  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

  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

  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

  The checklist will be administred once. Before the neurological examination

• Perceived health status (PHS)

  The PHS will be administred once. Before the neurological examination

Study Arms (1)

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.

Diagnostic Test: Vagus Nerve Neurodynamic test

Interventions

Vagus Nerve Neurodynamic test DIAGNOSTIC_TEST

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.

Also known as: Heart rate monitoring using a digital pulsossimeter

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy subjects that want to participate in the study

You may qualify if:

• Subjects aged between 18 and 70 years old
• Subjects that have signed the written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead
• Politecnico di Milano: collaborator

Study Sites (1)

Movement and Posture Analysis Lab

Milan, MI, 20100, Italy

Location

Related Publications (1)

• 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.

  PMID: 34552462 DERIVED

MeSH Terms

Conditions

Vagus Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Giacomo Carta, Msc

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: December 5, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 16, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following the publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

IT (1)