Clinical trial NCT05070273: Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study
Official title: Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: hypoglossal nerve
Lead sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The possibility of registering the M-response and the motor evoked potential (MEP) from the muscles of the tongue by using the St. Mark's electrode will be evaluated. The safety of method will be confirmed. Registered parameters will be compared with other known methods and comparative effectiveness of proposed method will be determined.

The study will involve healthy volunteers without clinical symptoms of hypoglossal nerve and cortico-lingual pathway lesions and without surgical interventions in the tongue .The volunteers will be examined once for the parameters of the amplitude and latency of the M-response and MEP, as well as the difference between these indicators at different sides of the examination during nerve conduction study (NCS) and transcranial magnetic stimulation (TMS) of the hypoglossal nerve and the cortico-lingual pathway.


Eligibility criteria: Inclusion criteria:

* Absence of clinical symptoms of impaired hypoglossal nerve and cortico-lingual pathways;
* Absence of history of surgical interventions in the tongue area;
* The subject has read the information sheet and signed the informed consent.

Exclusion Criteria:

* Clinical symptoms of hypoglossal nerve or cortico-lingual pathway (dysarthria, dysphagia (pseudobulbar palsy) lesions, flaccid paralysis of the tongue muscles, atrophy and fasciculations of the tongue muscles);
* Tumors, metastatic lesions and cysts in the region of the brain stem, posterior cranial fossa, base of the skull, in the region of the carotid segment, salivary glands;
* Vascular pathologies in the carotid sinus area: vascular malformations, dissection of the internal carotid artery aneurysm, venous thrombosis;
* Recent dental procedures with one of the following complications: development of an abscess, direct injury to the nerve by medical equipment, development of hematoma;
* History of carotid endarterectomy;
* Motor neuron disease and other neurodegenerative or demyelinating diseases;
* History of cancer and courses of radiation therapy;
* The presence of implantable programmable devices.

Primary outcomes:
measure: Severe adverse reactions and events rate
timeFrame: During the intervention and 1 day after the intervention
Secondary outcomes:
measure: Rate of M-wave registration during NCS of hypoglossus nerve using the St. Mark's electrode in healthy volunteers.
timeFrame: During the intervention
measure: Rate of MEP registration during TMS of cortical-lingual pathway using the St. Mark's electrode in healthy volunteers.
timeFrame: During the intervention
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov National Medical and Surgical Center
Study officials:
References: