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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoglossal nerve conduction study. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglossal nerve conduction study | Diagnostic Test | NCS of nervus hypoglossus (evaluation of M-response parameters) was carried out using a 4-channel electromyographic machine. The stimulation will be carried out from three points:
The initial stimulation parameters: strength of an electric current 20 mA, stimulus duration 0.2 ms, and frequency 1 Hz. To achieve supramaximal stimulation, the stimulation strength will be increased with a step of 1-2 mA to a maximum of 35 mA, the duration of the stimulus will be increased to 0.3 ms. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe adverse reactions and events rate | Severe adverse reactions and events will be monitored and registered during procedure of nerve stimulation and on the day of study | During the intervention and 1 day after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of M-wave registration during NCS of hypoglossus nerve using the St. Mark's electrode in healthy volunteers. | M-wave will be recorded during NCS from three points: A - the angle of the lower jaw (proximal point); B - the area of the carotid triangle (distal point); C - directly from the electrode of St. Mark when it is located on the muscles of the tongue. Stimulation will be carried out with stimuli with a duration of 0.2 ms, a frequency of 1 Hz with a gradual increase in the intensity of the stimulus until supramaximal stimulation will be achieved (maximum up to 35 mA). If necessary, the duration of the stimulus will be increased up to 0.3 ms. |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pirogov National Medical and Surgical Center | Moscow | 105064 | Russia |
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2 months after completion of the study
upon the request
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| Transcranial magnetic stimulation of hypoglossal nerve | Diagnostic Test | TMS will be carried out using a Magstim 200 magnetic stimulator connected with a BiStim module (Magstim Co. Ltd., Whitland, Wales, UK). The generated magnetic pulses will be delivered by the coil 65 mm in diameter tangentially located relative to the scalp in the F7 projection - T3 and F8-T4 (according to the international scheme "10-20"). The area of cortical stimulation will be localized by supplying single pulses with gradual increase, with a coil displacement with a step of 1 cm, until the contraction of the facial muscles will be obtained, followed by the determination of the MEP threshold value. Analysis of conduction by cortical-lingual pathway will be performed at TMS with magnetic stimulus intensity 20-30% above the MEP threshold. |
|
| During the intervention |
| Rate of MEP registration during TMS of cortical-lingual pathway using the St. Mark's electrode in healthy volunteers. | The generated magnetic pulses will be delivered by the coil 65 mm in diameter tangentially located relative to the scalp in the F7 projection - T3 and F8-T4 (according to the international scheme "10-20"). The area of cortical stimulation will be localized by supplying single pulses with gradual increase, with a coil displacement with a step of 1 cm, until the contraction of the facial muscles will be obtained, followed by the determination of the MEP threshold value. Analysis of conduction by cortical-lingual pathway will be performed at TMS with magnetic stimulus intensity 20-30% above the MEP threshold. | During the intervention |