Clinical trial NCT04192877: Validity and Inter-rater Reliability fo the Vagus Nerve Neurodynamic Test Among Healthy Subjects
Official title: Validation and Inter-rater Reliability of the Vagus Nerve Neurodynamic Test Among Healthy Subjects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vagus Nerve Diseases
Diagnoses Disease
Keywords: Validation Studies
Vagus Nerve Diseases
Diagnostic imaging
Motion analysis
Healthy Volunteers
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
First posted: 2019-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects that want to participate in the study

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.

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_

Eligibility criteria: 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.

Primary outcomes:
measure: Vagus nerve neurodynamic test (VN-NDT)
timeFrame: The test will be administered twice for each side, once by an expert and once by a novice.
measure: Ultrasound imaging (USI)
timeFrame: USI will be administered twice for each side, once by an expert and once by a novice.
measure: Motion capture analysis (MCA)
timeFrame: MCA will be used for the duration the VN-NDT administered twice for each side, once by an expert and once by a novice.
measure: Short-term autonomic response (STAR)
timeFrame: 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:
measure: Checklist for symptoms related to autonomic peripheral neuropathy (APN) and VN dysfunction
timeFrame: The checklist will be administred once. Before the neurological examination
measure: Perceived health status (PHS)
timeFrame: The PHS will be administred once. Before the neurological examination
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Movement and Posture Analysis Lab
state: MI
Study officials:
affiliation: University of Turin, Italy
name: Giacomo Carta, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.