Data Collection of Standard Care of Patients in the EMG Section

Neuropathy Clinical Trial

Official title:

Data Collection of Standard Care of Patients in the EMG Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041387
• Other study ID #: 10000560
• Secondary ID: 000560-N
• Status: Recruiting
• Start date: June 26, 2024
• Est. completion date: May 1, 2031

Study information

• Verified date: April 4, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Candida Silva
• Phone: (301) 496-7428
• Email: candida.silva[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

PROTOCOL SUMMARY

Title:

Data Collection for Standard Care of Patients in the EMG Section

Study Description:

This protocol is designed to provide 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 provide 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 provide a repository of information on enrolled participants to allow for hypothesis generation in future research.

Study Population:

The study population includes patients, male or female, who are age 18 or older with no upper age limit restrictions. The study population will be limited to 200. They may have neuromuscular disorder or neurodegenerative disorder.

Description of Sites/Facilities Enrolling Participants:

NINDS Intramural Clinical Research Program located in the NIH Clinical Center, Bethesda, MD.

Study Duration:

Participant Duration:

The current estimated study duration is 10 years. An extension to this study duration may be requested in the future via an amendment.

There is no specific time limitation on participant visits, though many participants may have only 1-2 visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2031
• Est. primary completion date: May 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Dysautonomia
• Muscle Disorders
• Muscular Diseases
• Neuropathy
• Primary Dysautonomias

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NIH Clinical Center Detailed Web Page