MedDataX Logo

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

NCT ID: NCT04192877

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-05

Study Completion Date

2019-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

\_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

See the medical conditions and disease areas that this research is targeting or investigating.

Vagus Nerve Diseases Diagnoses Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Validation Studies Vagus Nerve Diseases Diagnostic imaging Motion analysis Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Vagus Nerve Neurodynamic test

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vagus Nerve Neurodynamic 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Heart rate monitoring using a digital pulsossimeter

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Politecnico di Milano

OTHER

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giacomo Carta

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giacomo Carta, Msc

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Movement and Posture Analysis Lab

Milan, MI, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34552462 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

139870-14/03/2019

Identifier Type: -

Identifier Source: org_study_id