LarynxNCT02761239
Innervation of Human Cricopharyngeal Muscle By Recurrent Laryngeal and External Branch of Superior Laryngeal Nerve
A study testing The NIM 3.0 Nerve Monitoring System in people with Larynx, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN) and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human cricopharyngeal muscle (CP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Larynx
- What is being tested?
- The NIM 3.0 Nerve Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Nov 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who underwent thyroidectomy.
Who cannot join
- Preoperative RLN palsy
- Thyroid cancer with massive extrathyroidal extension
- Intentional nerve transection because of cancer invasion
- The assessment failure of nerve function due to the technical deficiency of the IONM equipment
About this study
Official title: Descriptive In Vivo Study of Evaluating the Innervation of The Human Cricopharyngeal Muscle By The Recurrent Laryngeal Nerve and External Branch of The Superior Laryngeal Nerve
The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN) and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during thyroidectomy with intraoperative neuromonitoring (IONM).
Read the detailed description
This study group consisted of a consecutive patients undergoing thyroid surgery with intraoperative neuromonitoring (NIM 3.0 Nerve Monitoring Systeme (Medtronic Xomed, Jacksonville, FL, USA) ) for various diseases. In all patients, each side of the neck operated was considered as a separate entity in our study.
EMG recordings were accomplished with a pair of needle electrodes inserted into the CP and mid-portion of the CT muscle that is located on the superior side of the RLN, which were plugged into the third and fourth channels of interface-connector box, respectively, at the end of the thyroidectomy or lobectomy. The investigators evaluated the innervation pattern of the CT muscle in an other study. Therefore the EBSLN is the main supplier of the CT muscle, the EMG findings of the CT muscle were used to confirm it, in this study.
EBSLN, pharyngeal plexus (PP), RLN and vagus nerve were stimulated with a monopolar stimulator probe at 1 mA. While stimulating these nerves, the ipsilateral CP muscle was visually observed for possible contractions and electromyographic recordings were obtained with the 4-channel NIM 3.0 Nerve Monitoring System.
- Conditions
- Larynx
- Being tested
- The NIM 3.0 Nerve Monitoring System
- Keywords
- cricopharyngeal muscle, innervation by EBSLN, A prospective case-controlled study
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The NIM 3.0 Nerve Monitoring SystemDevice
Electromyography recordings were accomplished with a pair of needle electrodes inserted through the CP muscle, which were plugged into the third and fourth channels of interface-connector box.The recurrent laryngeal nerve(RLN), vagus nerve, external branch of the superior laryngeal nerve(EBSLN) and pharyngeal plexus were stimulated with a current of 1 mA and a frequency of 4 MHz and the event threshold at 100 microV.
| Study group | Role | What they receive |
|---|---|---|
| Cricopharyngeal muscle innervation | Other | The recurrent laryngeal nerve (RLN), vagus nerve, external branch of the superior laryngeal nerve (EBSLN) and pharyngeal plexus were stimulated intraoperatively by the NIM 3.0 Nerve Monitoring System (Medtronic Xomed, Jacksonville, FL, USA). Responses were evaluated by visual observation of the cricopharyngeal muscle and electromyographies via needle electrodes inserted into the cricopharyngeal muscle. Receives: Device: The NIM 3.0 Nerve Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cricopharyngeal muscle innervation pattern that is evaluated by visual contractions and EMG evoked potentials, with stimulation of the nerves
Measured: up to 9 months
Secondary outcomes (1)
The comparison of the EMG amplitudes obtained with the stimulation of the recurrent laryngeal nerve (RLN), vagus nerve, external branch of the superior laryngeal nerve (EBSLN) and pharyngeal plexus.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LarynxStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Uludag, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Mehmet Uludag, Professor, Study director, Sisli Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761239
- Sponsor's protocol ID
- SEEAH02
- Status last verified
- May 2016
- First submitted
- 9 Sep 2015
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mu L, Sanders I. Neuromuscular specializations within human pharyngeal constrictor muscles. Ann Otol Rhinol Laryngol. 2007 Aug;116(8):604-17. doi: 10.1177/000348940711600809.
PubMed 17847729Sasaki CT, Kim YH, Sims HS, Czibulka A. Motor innervation of the human cricopharyngeus muscle. Ann Otol Rhinol Laryngol. 1999 Dec;108(12):1132-9. doi: 10.1177/000348949910801207.
PubMed 10605917Brok HA, Copper MP, Stroeve RJ, Ongerboer de Visser BW, Venker-van Haagen AJ, Schouwenburg PF. Evidence for recurrent laryngeal nerve contribution in motor innervation of the human cricopharyngeal muscle. Laryngoscope. 1999 May;109(5):705-8. doi: 10.1097/00005537-199905000-00005.
PubMed 10334217Halum SL, Shemirani NL, Merati AL, Jaradeh S, Toohill RJ. Electromyography findings of the cricopharyngeus in association with ipsilateral pharyngeal and laryngeal muscles. Ann Otol Rhinol Laryngol. 2006 Apr;115(4):312-6. doi: 10.1177/000348940611500411.
PubMed 16676829Oezcelik A, DeMeester SR. General anatomy of the esophagus. Thorac Surg Clin. 2011 May;21(2):289-97, x. doi: 10.1016/j.thorsurg.2011.01.003.
PubMed 21477778Mu L, Sanders I. The innervation of the human upper esophageal sphincter. Dysphagia. 1996 Fall;11(4):234-8. doi: 10.1007/BF00265207.
PubMed 8870349Prades JM, Timoshenko AP, Asanau A, Gavid M, Benakki H, Dubois MD, Faye MB, Martin C. [The cricopharyngeal muscle and the laryngeal nerves: contribution to the functional anatomy of swallowing]. Morphologie. 2009 Aug-Sep;93(301):35-41. doi: 10.1016/j.morpho.2009.07.001. Epub 2009 Oct 7. French.
PubMed 19815444
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive In Vivo Study of Evaluating the Innervation of The Human Cricopharyngeal Muscle By The Recurrent Laryngeal Nerve and External Branch of The Superior Laryngeal Nerve
- ClinicalTrials.gov ID
- NCT02761239
- Acronym / sponsor ID
- SEEAH02
- Conditions
- Larynx
- Keywords
- cricopharyngeal muscle, innervation by EBSLN, A prospective case-controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 May 2016 (estimated)
- 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 investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN) and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during thyroidectomy with intraoperative neuromonitoring (IONM).
Detailed description
This study group consisted of a consecutive patients undergoing thyroid surgery with intraoperative neuromonitoring (NIM 3.0 Nerve Monitoring Systeme (Medtronic Xomed, Jacksonville, FL, USA) ) for various diseases. In all patients, each side of the neck operated was considered as a separate entity in our study.
EMG recordings were accomplished with a pair of needle electrodes inserted into the CP and mid-portion of the CT muscle that is located on the superior side of the RLN, which were plugged into the third and fourth channels of interface-connector box, respectively, at the end of the thyroidectomy or lobectomy. The investigators evaluated the innervation pattern of the CT muscle in an other study. Therefore the EBSLN is the main supplier of the CT muscle, the EMG findings of the CT muscle were used to confirm it, in this study.
EBSLN, pharyngeal plexus (PP), RLN and vagus nerve were stimulated with a monopolar stimulator probe at 1 mA. While stimulating these nerves, the ipsilateral CP muscle was visually observed for possible contractions and electromyographic recordings were obtained with the 4-channel NIM 3.0 Nerve Monitoring System.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cricopharyngeal muscle innervation | Other | Device: The NIM 3.0 Nerve Monitoring SystemThe recurrent laryngeal nerve (RLN), vagus nerve, external branch of the superior laryngeal nerve (EBSLN) and pharyngeal plexus were stimulated intraoperatively by the NIM 3.0 Nerve Monitoring System (Medtronic Xomed, Jacksonville, FL, USA). Responses were evaluated by visual observation of the cricopharyngeal muscle and electromyographies via needle electrodes inserted into the cricopharyngeal muscle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who underwent thyroidectomy.
Key exclusion criteria (4 listed)
- Preoperative RLN palsy
- Thyroid cancer with massive extrathyroidal extension
- Intentional nerve transection because of cancer invasion
- The assessment failure of nerve function due to the technical deficiency of the IONM equipment
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 |
|---|---|---|
| The NIM 3.0 Nerve Monitoring SystemElectromyography recordings were accomplished with a pair of needle electrodes inserted through the CP muscle, which were plugged into the third and fourth channels of interface-connector box.The recurrent laryngeal nerve(RLN), vagus nerve, external branch of the superior laryngeal nerve(EBSLN) and pharyngeal plexus were stimulated with a current of 1 mA and a frequency of 4 MHz and the event threshold at 100 microV. | Device | Cricopharyngeal muscle innervation |
Primary outcome
The cricopharyngeal muscle innervation pattern that is evaluated by visual contractions and EMG evoked potentials, with stimulation of the nerves
Time frame: up to 9 months
1 secondary outcome
The comparison of the EMG amplitudes obtained with the stimulation of the recurrent laryngeal nerve (RLN), vagus nerve, external branch of the superior laryngeal nerve (EBSLN) and pharyngeal plexus.
Time frame: up to 9 months
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 4 May 2016.
- Background: PubMed 17847729Mu L, Sanders I. Neuromuscular specializations within human pharyngeal constrictor muscles. Ann Otol Rhinol Laryngol. 2007 Aug;116(8):604-17. doi: 10.1177/000348940711600809.
- Background: PubMed 10605917Sasaki CT, Kim YH, Sims HS, Czibulka A. Motor innervation of the human cricopharyngeus muscle. Ann Otol Rhinol Laryngol. 1999 Dec;108(12):1132-9. doi: 10.1177/000348949910801207.
- Background: PubMed 10334217Brok HA, Copper MP, Stroeve RJ, Ongerboer de Visser BW, Venker-van Haagen AJ, Schouwenburg PF. Evidence for recurrent laryngeal nerve contribution in motor innervation of the human cricopharyngeal muscle. Laryngoscope. 1999 May;109(5):705-8. doi: 10.1097/00005537-199905000-00005.
- Background: PubMed 16676829Halum SL, Shemirani NL, Merati AL, Jaradeh S, Toohill RJ. Electromyography findings of the cricopharyngeus in association with ipsilateral pharyngeal and laryngeal muscles. Ann Otol Rhinol Laryngol. 2006 Apr;115(4):312-6. doi: 10.1177/000348940611500411.
- Results publication: PubMed 21477778Oezcelik A, DeMeester SR. General anatomy of the esophagus. Thorac Surg Clin. 2011 May;21(2):289-97, x. doi: 10.1016/j.thorsurg.2011.01.003.
- Results publication: PubMed 8870349Mu L, Sanders I. The innervation of the human upper esophageal sphincter. Dysphagia. 1996 Fall;11(4):234-8. doi: 10.1007/BF00265207.
- Results publication: PubMed 19815444Prades JM, Timoshenko AP, Asanau A, Gavid M, Benakki H, Dubois MD, Faye MB, Martin C. [The cricopharyngeal muscle and the laryngeal nerves: contribution to the functional anatomy of swallowing]. Morphologie. 2009 Aug-Sep;93(301):35-41. doi: 10.1016/j.morpho.2009.07.001. Epub 2009 Oct 7. French.
- Individual participant dataSharing planned: No
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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.
Mehmet Uludag, Professor study director
Sisli Etfal Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing The NIM 3.0 Nerve Monitoring System in people with Larynx, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 1 inclusion and 4 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The cricopharyngeal muscle innervation pattern that is evaluated by visual contractions and EMG evoked potentials, with stimulation of the nerves (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761239, which also lists 7 linked publications.
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 4 May 2016.