Myasthenia GravisNCT05337891
Sensitivity of Repetitive Nerve Stimulation Performed in the Evening vs in the Morning in Myasthenia Gravis
An observational study of Myasthenia Gravis, run by Jagiellonian University at 1 site in Poland.
Trial summary
Myasthenia gravis (MG) is the autoimmune disorder affecting the neuromuscular junction, characterized by fatigue, which increases gradually through the day. The repetitive nerve stimulation (RNS) remains the key diagnostic test in MG, however its sensitivity, especially in ocular form of MG is not satisfactory. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jun 2022to 1 Sep 2026
- Phase
- Observational
- 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
Study population: Convenience sample of 40 people with suspected or diagnosed myasthenia gravis (ocular and generalized form). Patients will be recruited from the Outpatient Clinic of the Neurology Clinic of University Hospital in Cracow
Who may be able to join
- Patients with suspected or diagnosed myasthenia gravis (ocular and generalized form)
- Patients with performed or planned determination of anti-AChrR and anti-MUSK antibodies.
- Disease severity of at least 1 in the classification of the severity of myasthenia gravis according to the recommendations of the Myasthenia Gravis Foundation of America
Who cannot join
- respiratory failure
- severe bulbar symptoms
- pharmacotherapy with substances that may worsen neuromuscular transmission disorders
- current infection
- coexisting diseases of the peripheral nervous system which may affect the result of the fatigue test, e.g. polyneuropathy or myopathy
- cognitive and behavioral disorders that may negatively affect patient's adherence to study protocol
- Medication with steroids due to myasthenia
- Severity of myasthenia that makes the discontinuation of acetylcholinesterase inhibitors unsafe.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University Medical College, Department of Neurology
Krakow, Lesser Poland Voivodeship, 31503
Jakub M Antczak, MD, +48 795 421 153, jakub.antczak@uj.edu.pl
Gabriela Rusin, MD, +48 601 661 607, gabriela.rusin@doctoral.uj.edu.pl
About this study
Official title: Sensitivity of Repetitive Nerve Stimulation Performed in the Evening vs in the Morning and With Single vs Repeated Effort in Myasthenia Gravis
Myasthenia gravis (MG) is the autoimmune disorder affecting the neuromuscular junction, characterized by fatigue, which increases gradually through the day. The repetitive nerve stimulation (RNS) remains the key diagnostic test in MG, however its sensitivity, especially in ocular form of MG is not satisfactory. In this study, investigators want to assess the impact of the time of the day on the sensitivity of the RNS. We hypothesize the RNS performed in the evening may be more sensitive than in the morning.
Read the detailed description
Myasthenia gravis (MG) is the autoimmune disorder affecting the neuromuscular junction with morbidity estimated at 70-320 per 1 000 000. The main symptom is the fatigue, which increases gradually through the day and also after exercise. The repetitive nerve stimulation (RNS) remains the key diagnostic test. In RNS, the peripheral nerve is electrically stimulated with trains of repetitive pulses at constant (e.g. 3Hz) frequency. The electrical responses associated with contraction of the one of respectively innervated muscles are recorded. While in healthy subject the amplitudes of subsequent responses should be similar, in MG they gradually decrease reflecting the insufficiency of neuromuscular junction and being the electrophysiological correlate of the fatigue. RNS is relatively simple, safe as well as time and cost-effective procedure. However, its sensitivity is not satisfactory. Even when voluntary exercise and other provocative methods are implemented, the sensitivity does not exceed 89% in generalized form of MG (where symptoms affect bulbar, limb and other muscles) and 70% in ocular form (where symptoms are limited to bulbar muscles). In some laboratories the sensitivity of detecting the impaired neuromuscular transmission can be increased with the use of the single fiber electromyography. This method is however not widely available as it requires skilled personnel and dedicated software. It is also not specific for MG. Therefore, research effort is still being done to increase the sensitivity of the RNS. The well-known gradual exacerbation of MG-related fatigue through the day let us to hypothesize, the RNS performed in the evening may be more sensitive than in the morning. The primary objective of this study will be therefore a comparison of RNS sensitivity performed in these both times of the day. Additionally, investigators want to assess if adding the second voluntary effort could be another way of improving the RNS-sensitivity. The maximal voluntary effort of the investigated muscle, lasting between 30 seconds and one minute is typically done in the course of the RNS. Usually, one or several trains of five to ten impulses precede it and also several trains follow it. While prolonging the effort over one minute may cause discomfort or problems with adherence, adding second one-minute effort, separated from the first by several trains should be suitable and well tolerable. It will prolong the whole procedure by approximately six minutes minutes.
Diagnostic procedure: In every recruited patient, RNS will be done thrice at 8:30 a.m., 8:50 a.m. and 2:30 p.m. on the same day or at 8:30 a.m. and 8:50 a.m. on one day and at 2:30 p.m. on the subsequent day. To exclude peripheral neuropathy, before the first RNS, the sensory nerve conduction study will be performed on the sural nerve and the motor conduction study on the tibial nerve on the nondominant side. To exclude myopathy, before the first RNS, the needle electromyography will be performed on the biceps brachii, of dominant side. Also, before the first RNS, the Myasthenia Gravis - Activities of Daily Living Score (MG-ADL) will be filled out. Every RNS will comprise investigation of the nasalis and trapezius muscles on the clinically more affected side or on the nondominant side when lateralization will not be evident. Investigation of every muscle will include two, 3Hz trains of ten supramaximal electric stimuli, separated by 1 minute interval. Then the 1 minute of maximal voluntary effort will follow and after that six 3Hz trains of ten supramaximal stimuli, separated by 1-minute intervals. The first or the second RNS (at 8:30 or at 8:50 a.m.) will include additional 1 minute of maximal voluntary effort, followed by additional six 3Hz trains of ten supramaximal stimuli, separated by 1-minute intervals. The allocation of the additional voluntary effort and subsequent six trains to the first or to the second RNS will be done randomly. The randomization list will be created via the website www.randomization.com using blocks of five subjects. The amplitude drop (the decrement) of the fourth response (out of 10 in every train) >=10% with respect to the first response will be considered abnormal (indicative of impaired neuromuscular transmission). The whole RNS will be considered abnormal (indicative of impaired neuromuscular transmission) when the decrement >=10% will be repeatable in at least several trains in at least one out of two tested muscles. The temperature of the skin will be maintained at 35 Celsius. If being taken, the acetylcholinesterase inhibitors will be withheld 12 hours before the first RNS.
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Repetitive Nerve Stimulation, effort, Morning, Evening
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected or diagnosed myasthenia gravis | Patients with suspected or diagnosed myasthenia gravis (ocular and generalized form), aged 18-80, both sexes, with performed or planned determination of anti-acetylcholine receptor antibodies and muscle-specific tyrosine kinase antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the highest decrement between investigation of nasalis during morning and evening RNS
Difference in the highest decrement between investigation of nasalis during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS at 2:30 p.m.
Measured: Through study completion, an average of 1 year.
Difference in the highest decrement between investigation of trapezius during morning and evening RNS
Difference in the highest decrement between investigation of trapezius during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS at 2:30 p.m.
Measured: Through study completion, an average of 1 year.
Difference in the highest decrement between investigation of nasalis during morning RNS with single and with two voluntary efforts
Difference in the highest decrement between investigation of nasalis during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS with two one-minute voluntary efforts.
Measured: Through study completion, an average of 1 year.
Difference in the highest decrement between investigation of trapezius during morning RNS with single and with two voluntary efforts
Difference in the highest decrement between investigation of trapezius during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS with two one-minute voluntary efforts.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (5)
Difference in the percentage of abnormal RNS results between RNS performed in the morning and in the evening
Difference in the percentage of abnormal RNS results between RNS with single one-minute voluntary effort performed in the morning (at 8:30 or 8:50 a.m.) and RNS performed at 2:30 p.m.
Measured: Through study completion, an average of 1 year.
Difference in the percentage of abnormal RNS results between RNS performed in the morning with single and with two voluntary efforts
Difference in the percentage of abnormal RNS results between RNS with single one-minute voluntary effort performed at 8:30 or 8:50 a.m. and RNS with two one-minute voluntary efforts.
Measured: Through study completion, an average of 1 year.
Correlation between the highest decrement during morning RNS with single one-minute voluntary effort and the MG-ADL score
Correlation between the highest decrement during RNS with single one-minute voluntary effort, performed at 8:30 or 8:50 AM and the MG-ADL score
Measured: Through study completion, an average of 1 year.
Correlation between the highest decrement during RNS with two one-minute voluntary efforts and the MG-ADL score
Correlation between the highest decrement during RNS with two one-minute voluntary efforts, and the MG-ADL score
Measured: Through study completion, an average of 1 year.
Correlation between the highest decrement during evening RNS and the MG-ADL score
Correlation between the highest decrement during RNS performed at 2:30 p.m. and the MG-ADL score
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start3 Jun 2022
- Primary completion1 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Antczak, Jagiellonian University
- Investigators
- Jakub M Antczak, MD, Principal investigator, Jagiellonian University Medical College, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337891
- Sponsor's protocol ID
- JagiellonianU70
- Status last verified
- Oct 2024
- First submitted
- 13 Apr 2022
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completing the study, the age and gender of participants as well as the scores and results of all outcome measurements together with electrophysiological recordings will be made available to other researchers on request.
Publications
Witoonpanich R, Dejthevaporn C, Sriphrapradang A, Pulkes T. Electrophysiological and immunological study in myasthenia gravis: diagnostic sensitivity and correlation. Clin Neurophysiol. 2011 Sep;122(9):1873-7. doi: 10.1016/j.clinph.2011.02.026. Epub 2011 Mar 17.
PubMed 21419697Bou Ali H, Salort-Campana E, Grapperon AM, Gallard J, Franques J, Sevy A, Delmont E, Verschueren A, Pouget J, Attarian S. New strategy for improving the diagnostic sensitivity of repetitive nerve stimulation in myasthenia gravis. Muscle Nerve. 2017 Apr;55(4):532-538. doi: 10.1002/mus.25374. Epub 2017 Jan 3.
PubMed 27511866Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology. 1999 Apr 22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487.
PubMed 10227640Jaretzki A 3rd, Barohn RJ, Ernstoff RM, Kaminski HJ, Keesey JC, Penn AS, Sanders DB. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology. 2000 Jul 12;55(1):16-23. doi: 10.1212/wnl.55.1.16. No abstract available.
PubMed 10891897
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of Repetitive Nerve Stimulation Performed in the Evening vs in the Morning and With Single vs Repeated Effort in Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT05337891
- Acronym / sponsor ID
- JagiellonianU70
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Repetitive Nerve Stimulation, effort, Morning, Evening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 20 Apr 2022 (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.
Myasthenia gravis (MG) is the autoimmune disorder affecting the neuromuscular junction, characterized by fatigue, which increases gradually through the day. The repetitive nerve stimulation (RNS) remains the key diagnostic test in MG, however its sensitivity, especially in ocular form of MG is not satisfactory. In this study, investigators want to assess the impact of the time of the day on the sensitivity of the RNS. We hypothesize the RNS performed in the evening may be more sensitive than in the morning.
Detailed description
Myasthenia gravis (MG) is the autoimmune disorder affecting the neuromuscular junction with morbidity estimated at 70-320 per 1 000 000. The main symptom is the fatigue, which increases gradually through the day and also after exercise. The repetitive nerve stimulation (RNS) remains the key diagnostic test. In RNS, the peripheral nerve is electrically stimulated with trains of repetitive pulses at constant (e.g. 3Hz) frequency. The electrical responses associated with contraction of the one of respectively innervated muscles are recorded. While in healthy subject the amplitudes of subsequent responses should be similar, in MG they gradually decrease reflecting the insufficiency of neuromuscular junction and being the electrophysiological correlate of the fatigue. RNS is relatively simple, safe as well as time and cost-effective procedure. However, its sensitivity is not satisfactory. Even when voluntary exercise and other provocative methods are implemented, the sensitivity does not exceed 89% in generalized form of MG (where symptoms affect bulbar, limb and other muscles) and 70% in ocular form (where symptoms are limited to bulbar muscles). In some laboratories the sensitivity of detecting the impaired neuromuscular transmission can be increased with the use of the single fiber electromyography. This method is however not widely available as it requires skilled personnel and dedicated software. It is also not specific for MG. Therefore, research effort is still being done to increase the sensitivity of the RNS. The well-known gradual exacerbation of MG-related fatigue through the day let us to hypothesize, the RNS performed in the evening may be more sensitive than in the morning. The primary objective of this study will be therefore a comparison of RNS sensitivity performed in these both times of the day. Additionally, investigators want to assess if adding the second voluntary effort could be another way of improving the RNS-sensitivity. The maximal voluntary effort of the investigated muscle, lasting between 30 seconds and one minute is typically done in the course of the RNS. Usually, one or several trains of five to ten impulses precede it and also several trains follow it. While prolonging the effort over one minute may cause discomfort or problems with adherence, adding second one-minute effort, separated from the first by several trains should be suitable and well tolerable. It will prolong the whole procedure by approximately six minutes minutes.
Diagnostic procedure: In every recruited patient, RNS will be done thrice at 8:30 a.m., 8:50 a.m. and 2:30 p.m. on the same day or at 8:30 a.m. and 8:50 a.m. on one day and at 2:30 p.m. on the subsequent day. To exclude peripheral neuropathy, before the first RNS, the sensory nerve conduction study will be performed on the sural nerve and the motor conduction study on the tibial nerve on the nondominant side. To exclude myopathy, before the first RNS, the needle electromyography will be performed on the biceps brachii, of dominant side. Also, before the first RNS, the Myasthenia Gravis - Activities of Daily Living Score (MG-ADL) will be filled out. Every RNS will comprise investigation of the nasalis and trapezius muscles on the clinically more affected side or on the nondominant side when lateralization will not be evident. Investigation of every muscle will include two, 3Hz trains of ten supramaximal electric stimuli, separated by 1 minute interval. Then the 1 minute of maximal voluntary effort will follow and after that six 3Hz trains of ten supramaximal stimuli, separated by 1-minute intervals. The first or the second RNS (at 8:30 or at 8:50 a.m.) will include additional 1 minute of maximal voluntary effort, followed by additional six 3Hz trains of ten supramaximal stimuli, separated by 1-minute intervals. The allocation of the additional voluntary effort and subsequent six trains to the first or to the second RNS will be done randomly. The randomization list will be created via the website www.randomization.com using blocks of five subjects. The amplitude drop (the decrement) of the fourth response (out of 10 in every train) >=10% with respect to the first response will be considered abnormal (indicative of impaired neuromuscular transmission). The whole RNS will be considered abnormal (indicative of impaired neuromuscular transmission) when the decrement >=10% will be repeatable in at least several trains in at least one out of two tested muscles. The temperature of the skin will be maintained at 35 Celsius. If being taken, the acetylcholinesterase inhibitors will be withheld 12 hours before the first RNS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected or diagnosed myasthenia gravis | – | –Patients with suspected or diagnosed myasthenia gravis (ocular and generalized form), aged 18-80, both sexes, with performed or planned determination of anti-acetylcholine receptor antibodies and muscle-specific tyrosine kinase antibodies |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample of 40 people with suspected or diagnosed myasthenia gravis (ocular and generalized form). Patients will be recruited from the Outpatient Clinic of the Neurology Clinic of University Hospital in Cracow
Key inclusion criteria (3 listed)
- Patients with suspected or diagnosed myasthenia gravis (ocular and generalized form)
- Patients with performed or planned determination of anti-AChrR and anti-MUSK antibodies.
- Disease severity of at least 1 in the classification of the severity of myasthenia gravis according to the recommendations of the Myasthenia Gravis Foundation of America
Key exclusion criteria (8 listed)
- respiratory failure
- severe bulbar symptoms
- pharmacotherapy with substances that may worsen neuromuscular transmission disorders
- current infection
- coexisting diseases of the peripheral nervous system which may affect the result of the fatigue test, e.g. polyneuropathy or myopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in the highest decrement between investigation of nasalis during morning and evening RNS
Time frame: Through study completion, an average of 1 year.
Difference in the highest decrement between investigation of nasalis during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS at 2:30 p.m.
Difference in the highest decrement between investigation of trapezius during morning and evening RNS
Time frame: Through study completion, an average of 1 year.
Difference in the highest decrement between investigation of trapezius during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS at 2:30 p.m.
Difference in the highest decrement between investigation of nasalis during morning RNS with single and with two voluntary efforts
Time frame: Through study completion, an average of 1 year.
Difference in the highest decrement between investigation of nasalis during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS with two one-minute voluntary efforts.
Difference in the highest decrement between investigation of trapezius during morning RNS with single and with two voluntary efforts
Time frame: Through study completion, an average of 1 year.
Difference in the highest decrement between investigation of trapezius during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS with two one-minute voluntary efforts.
5 secondary outcomes
Difference in the percentage of abnormal RNS results between RNS performed in the morning and in the evening
Time frame: Through study completion, an average of 1 year.
Difference in the percentage of abnormal RNS results between RNS performed in the morning with single and with two voluntary efforts
Time frame: Through study completion, an average of 1 year.
Correlation between the highest decrement during morning RNS with single one-minute voluntary effort and the MG-ADL score
Time frame: Through study completion, an average of 1 year.
Correlation between the highest decrement during RNS with two one-minute voluntary efforts and the MG-ADL score
Time frame: Through study completion, an average of 1 year.
Correlation between the highest decrement during evening RNS and the MG-ADL score
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Results publication: PubMed 21419697Witoonpanich R, Dejthevaporn C, Sriphrapradang A, Pulkes T. Electrophysiological and immunological study in myasthenia gravis: diagnostic sensitivity and correlation. Clin Neurophysiol. 2011 Sep;122(9):1873-7. doi: 10.1016/j.clinph.2011.02.026. Epub 2011 Mar 17.
- Results publication: PubMed 27511866Bou Ali H, Salort-Campana E, Grapperon AM, Gallard J, Franques J, Sevy A, Delmont E, Verschueren A, Pouget J, Attarian S. New strategy for improving the diagnostic sensitivity of repetitive nerve stimulation in myasthenia gravis. Muscle Nerve. 2017 Apr;55(4):532-538. doi: 10.1002/mus.25374. Epub 2017 Jan 3.
- Results publication: PubMed 10227640Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology. 1999 Apr 22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487.
- Results publication: PubMed 10891897Jaretzki A 3rd, Barohn RJ, Ernstoff RM, Kaminski HJ, Keesey JC, Penn AS, Sanders DB. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology. 2000 Jul 12;55(1):16-23. doi: 10.1212/wnl.55.1.16. No abstract available.
- Individual participant dataSharing planned: Yes. After completing the study, the age and gender of participants as well as the scores and results of all outcome measurements together with electrophysiological recordings will be made available to other researchers on request.
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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.
Jakub M Antczak, MD principal investigator
Jagiellonian University Medical College, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Jagiellonian University at 1 site in Poland.
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: status not confirmed, as of the sponsor's last update on 10 Oct 2024. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakub M Antczak, MD (+48 795 421 153, jantczak@cm-uj.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the highest decrement between investigation of nasalis during morning and evening RNS (time frame: Through study completion, an average of 1 year.). The study lists 4 primary outcomes in all. 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 NCT05337891, which also lists 4 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 10 Oct 2024.