Healthy VolunteersNCT05070273
Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study
A study testing Hypoglossal nerve conduction study and Transcranial magnetic stimulation of hypoglossal nerve in people with Healthy Volunteers, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hypoglossal nerve conduction study and Transcranial magnetic stimulation of hypoglossal nerve
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2021to 10 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Volunteers
- Being tested
- Hypoglossal nerve conduction study, Transcranial magnetic stimulation of hypoglossal nerve
- Keywords
- hypoglossal nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal nerve conduction studyDiagnostic 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:
- angle of the lower jaw (proximal point),
- the area of the carotid triangle (distal point),
- directly from the electrode of St. Mark when it is localized on the muscles of the tongue.
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.
Transcranial magnetic stimulation of hypoglossal nerveDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Hypoglossal nerve conduction study. | Experimental | Not described Receives: Diagnostic Test: Hypoglossal nerve conduction study; Diagnostic Test: Transcranial magnetic stimulation of hypoglossal nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the intervention and 1 day after the intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Oct 2021
- Primary completion20 Oct 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070273
- Sponsor's protocol ID
- NMSC-03-21
- Status last verified
- Nov 2021
- First submitted
- 23 Sep 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study
- ClinicalTrials.gov ID
- NCT05070273
- Acronym / sponsor ID
- NMSC-03-21
- Conditions
- Healthy Volunteers
- Keywords
- hypoglossal nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoglossal nerve conduction study. | Experimental | Diagnostic Test: Hypoglossal nerve conduction study, Diagnostic Test: Transcranial magnetic stimulation of hypoglossal nerve |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglossal nerve conduction studyNCS 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: 1. angle of the lower jaw (proximal point), 2. the area of the carotid triangle (distal point), 3. directly from the electrode of St. Mark when it is localized on the muscles of the tongue. 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. | Diagnostic test | Hypoglossal nerve conduction study. |
| Transcranial magnetic stimulation of hypoglossal nerveTMS 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. | Diagnostic test | Hypoglossal nerve conduction study. |
Primary outcome
Severe adverse reactions and events rate
Time frame: During the intervention and 1 day after the intervention
Severe adverse reactions and events will be monitored and registered during procedure of nerve stimulation and on the day of study
2 secondary outcomes
Rate of M-wave registration during NCS of hypoglossus nerve using the St. Mark's electrode in healthy volunteers.
Time frame: During the intervention
Rate of MEP registration during TMS of cortical-lingual pathway using the St. Mark's electrode in healthy volunteers.
Time frame: During the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglossal nerve conduction study and Transcranial magnetic stimulation of hypoglossal nerve in people with Healthy Volunteers, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe adverse reactions and events rate (time frame: During the intervention and 1 day after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.