Data Collection of Standard Care of Patients in the EMG Section

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.

Study Overview

• Status: Recruiting
• Conditions: Neuropathy; Muscle Disorders; Dysautonomia

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Tanya J Lehky, M.D.; Phone Number: (301) 496-7428; Email: lehkyt@ninds.nih.gov
• Study Contact Backup: Name: Candida C Silva; Phone Number: (301) 496-7428; Email: candida.silva@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY8664111010 800-411-1222; Email: prpl@cc.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients will be referred by physician, clinic or may be self-referred.

Description

• INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

No other exclusion criteria for patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Neuromuscular disorders; Patients with neuromuscular disorders, no specific diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Collaborators and Investigators

• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Tanya J Lehky, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 7, 2026
• Last Verified: March 6, 2026

More Information

Terms related to this study

• Keywords: Screening; Standard of Care; NEUROMUSCULAR DISORDERS
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Autonomic Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 10000560; 000560-N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: As mentioned above, IPD will only be shared with the referring physician.
• IPD Sharing Access Criteria: No analysis or general data will be shared.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No