NeuropathyNCT05041387
Data Collection of Standard Care of Patients in the EMG Section
An observational study of Neuropathy and Muscle Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Most people who are referred to the EMG (Electromyography) Section of the NIH are enrolled into specific active studies. This allows researchers to learn about a range of rare neuromuscular disorders. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Neuropathy, Muscle Disorders, Dysautonomia
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 1 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be referred by physician, clinic or may be self-referred.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- The patient or the patient's Legally Authorized Representative is capable of informed consent and signs the consent form.
- Male or female, age 18 and over, no age limit
- Possible neuromuscular disorder or neurodegenerative disorder.
Who cannot join
- No other exclusion criteria for patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Background:
Most people who are referred to the EMG (Electromyography) Section of the NIH are enrolled into specific active studies. This allows researchers to learn about a range of rare neuromuscular disorders. But study criteria may not give researchers the chance to evaluate a single person or study a common symptom. Therefore, researchers want to assess people with neuromuscular disorders who are not currently enrolled in any NIH studies. They will perform tests on these individuals in the EMG Lab. Then they will create a repository of data that may be used for future research. This will help them learn more about these disorders.
Read more
Objective:
To retain data that is collected as part of participant visits to the NIH.
Eligibility:
People aged 18 and older who will be visiting the NIH for evaluation of their neuromuscular disorder.
Design:
Participants will be screened with a medical record review.
Participants will have a physical exam. They will be evaluated for their neuromuscular disorder. They may have tests to learn more about how their nerves and muscles work that are called nerve conduction and EMG studies. Their muscles and nerves may be assessed with an ultrasound. Their ability to sweat may be measured. Their heart rate and blood pressure may be taken. Changes to their breathing or changes in their body position may be measured.
Participant data will be given a unique numerical identifier that can be used if the data is shared. Data will be stored on a server and in a database.
Participants will have 1-2 visits. Each visit will last less than 4 hours. They may be contacted for a follow-up visit....
Read the detailed description
Study Description:
This protocol is designed to create a repository of information for future hypothesis generation. We will be evaluating patients with neuromuscular disorders that are not currently enrolled in any NIH protocols with procedures performed in the EMG Lab. The procedures include standard neurophysiological studies of EMG, autonomic nervous system (ANS) testing, and neuromuscular ultrasound (NMUS) as deemed necessary for appropriate diagnostic and clinical status testing. This will allow us to investigate into the problems of these patients with the purpose of furthering general knowledge of neuromuscular disorders and enhancing our EMG capabilities. Our ability to evaluate patients with a wide variety of neuromuscular diseases is also critical to maintaining our accreditation with the clinical neurophysiology fellowship programs and training our fellows to be competent physicians, as well as for keeping all staff, including senior staff, up-to-date and familiar with the evaluation of patients with a wide spectrum of diseases. We may also be able to later refer these patients into treatment protocols or re-evaluate patients that are no longer in an active NINDS protocol. This protocol will be valuable resource to the community by engendering greater interaction with the local neurologists and clinics as well as providing certain types of neurophysiological testing that are not readily available in the community.
Objectives:
To create a repository of information on enrolled participants to allow for hypothesis generation in future research
To add value to the Clinical Neurophysiology training programs by providing consult, diagnostic tests, and medical follow-up of participants
Endpoints:
To create a repository of information on enrolled participants to allow for hypothesis generation in future research.
- Conditions
- Neuropathy, Muscle Disorders, Dysautonomia
- Keywords
- Standard of Care, Screening, NEUROMUSCULAR DISORDERS
- Medical subject headings
- Muscular Diseases, Autonomic Nervous System Diseases, Neuromuscular Diseases
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 |
|---|---|---|
| Neuromuscular disorders | Patients with neuromuscular disorders, no specific diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide a repository of information on enrolled participants to allow for hypothesis generation in future research.
Results of patient's studies will be tabulated.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start24 Jun 2024
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tanya J Lehky, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041387
- Sponsor's protocol ID
- 10000560
- Other IDs
- 000560-N
- Status last verified
- 5 Aug 2026
- First submitted
- 10 Sep 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be shared with the referring physician and any other person the participant requests. The individual participant data will not be shared with anyone not involved in the care of that participant.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection of Standard Care of Patients in the EMG Section
- ClinicalTrials.gov ID
- NCT05041387
- Acronym / sponsor ID
- 10000560
- Conditions
- Neuropathy, Muscle Disorders, Dysautonomia
- Keywords
- Standard of Care, Screening, NEUROMUSCULAR DISORDERS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 13 Sep 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.
Background:
Most people who are referred to the EMG (Electromyography) Section of the NIH are enrolled into specific active studies. This allows researchers to learn about a range of rare neuromuscular disorders. But study criteria may not give researchers the chance to evaluate a single person or study a common symptom. Therefore, researchers want to assess people with neuromuscular disorders who are not currently enrolled in any NIH studies. They will perform tests on these individuals in the EMG Lab. Then they will create a repository of data that may be used for future research. This will help them learn more about these disorders.
Objective:
To retain data that is collected as part of participant visits to the NIH.
Eligibility:
People aged 18 and older who will be visiting the NIH for evaluation of their neuromuscular disorder.
Design:
Participants will be screened with a medical record review.
Participants will have a physical exam. They will be evaluated for their neuromuscular disorder. They may have tests to learn more about how their nerves and muscles work that are called nerve conduction and EMG studies. Their muscles and nerves may be assessed with an ultrasound. Their ability to sweat may be measured. Their heart rate and blood pressure may be taken. Changes to their breathing or changes in their body position may be measured.
Participant data will be given a unique numerical identifier that can be used if the data is shared. Data will be stored on a server and in a database.
Participants will have 1-2 visits. Each visit will last less than 4 hours. They may be contacted for a follow-up visit....
Detailed description
Study Description:
This protocol is designed to create a repository of information for future hypothesis generation. We will be evaluating patients with neuromuscular disorders that are not currently enrolled in any NIH protocols with procedures performed in the EMG Lab. The procedures include standard neurophysiological studies of EMG, autonomic nervous system (ANS) testing, and neuromuscular ultrasound (NMUS) as deemed necessary for appropriate diagnostic and clinical status testing. This will allow us to investigate into the problems of these patients with the purpose of furthering general knowledge of neuromuscular disorders and enhancing our EMG capabilities. Our ability to evaluate patients with a wide variety of neuromuscular diseases is also critical to maintaining our accreditation with the clinical neurophysiology fellowship programs and training our fellows to be competent physicians, as well as for keeping all staff, including senior staff, up-to-date and familiar with the evaluation of patients with a wide spectrum of diseases. We may also be able to later refer these patients into treatment protocols or re-evaluate patients that are no longer in an active NINDS protocol. This protocol will be valuable resource to the community by engendering greater interaction with the local neurologists and clinics as well as providing certain types of neurophysiological testing that are not readily available in the community.
Objectives:
To create a repository of information on enrolled participants to allow for hypothesis generation in future research
To add value to the Clinical Neurophysiology training programs by providing consult, diagnostic tests, and medical follow-up of participants
Endpoints:
To create a repository of information on enrolled participants to allow for hypothesis generation in future research.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular disorders | – | –Patients with neuromuscular disorders, no specific diagnosis |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be referred by physician, clinic or may be self-referred.
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- The patient or the patient's Legally Authorized Representative is capable of informed consent and signs the consent form.
- Male or female, age 18 and over, no age limit
- Possible neuromuscular disorder or neurodegenerative disorder.
Key exclusion criteria (1 listed)
- No other exclusion criteria for patients
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
To provide a repository of information on enrolled participants to allow for hypothesis generation in future research.
Time frame: 10 years
Results of patient's studies will be tabulated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The individual participant data will be shared with the referring physician and any other person the participant requests. The individual participant data will not be shared with anyone not involved in the care of that participant.
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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.
Tanya J Lehky, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Neuropathy and Muscle Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candida C Silva ((301) 496-7428, candida.silva@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide a repository of information on enrolled participants to allow for hypothesis generation in future research. (time frame: 10 years). 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 14 Sep 2026.