Data Collection of Standard Care of Patients in the EMG Section

NCT05041387 | Recruiting

• 2 other identifiers: 10000560000560-N
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neuropathy; Muscle Disorders; Dysautonomia

Keywords

Standard of Care; Screening; NEUROMUSCULAR DISORDERS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Neuromuscular disorders

Patients with neuromuscular disorders, no specific diagnosis

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Muscular Diseases; Autonomic Nervous System Diseases; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Nervous System Diseases

Study Officials

• Tanya J Lehky, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candida C Silva

CONTACT

(301) 496-7428; candida.silva@nih.gov

Tanya J Lehky, M.D.

CONTACT

(301) 496-7428; lehkyt@ninds.nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 13, 2021
• Study Start: June 24, 2024
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: March 10, 2026

Record last verified: 2026-03-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: As mentioned above, IPD will only be shared with the referring physician.
• Access Criteria: No analysis or general data will be shared.

Locations

US (1)