Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Status

Completed

Conditions

Healthy Volunteers

Treatments

Diagnostic Test: Transcranial magnetic stimulation of hypoglossal nerve

Diagnostic Test: Hypoglossal nerve conduction study

Study type

Interventional

Funder types

Other

Identifiers

NCT05070273

NMSC-03-21

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.