HealthyNCT00004553
Electromyography to Diagnose Neuromuscular Disorders
A study testing Electromyography in people with Healthy and Neuromuscular Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will investigate problems with muscle weakness and control using electromyography-a test of nerve-muscle cell communication. Advanced techniques called single fiber electromyography and macro-electromyography, which evaluate individual muscle fibers, will be used. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Neuromuscular Disease, Postpoliomyelitis Syndrome
- What is being tested?
- Electromyography
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Nov 2005
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients with weakness or motor dysfunction: 8/year.
- Normal volunteers, adults: 2/year.
Who cannot join
- Anticoagulation or uncorrected bleeding disorder.
- Children are not optimal subjects for fellows undergoing training in these techniques and will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Diagnosis of Neuromuscular Disorders With Specialized Electromyographic Studies
This study will investigate problems with muscle weakness and control using electromyography-a test of nerve-muscle cell communication. Advanced techniques called single fiber electromyography and macro-electromyography, which evaluate individual muscle fibers, will be used. Besides aiding in diagnosis, these tests provide information about disease progression that may be useful in guiding therapy.
Adult patients with suspected neurological disorders of muscle control and weakness may be eligible for this study. Normal volunteers may also participate. For the electromyography procedure, a special needle is inserted into a muscle. The patient will slightly tense the muscle and maintain the tension while electrical signals from the muscle fibers are being recorded. The electrical signals are played through a loudspeaker, providing feedback to help the patient tense the muscle the appropriate amount. The test, which is usually done for only one muscle, takes 1 to 2 hours. If needed, short breaks can be taken.
Read more
If the patient cannot maintain tension in the muscle for the entire test period, a nerve will be stimulated to activate the muscle. A thin needle is inserted near the nerve, and a series of small electrical shocks are given to activate a nerve fiber. The electromyography needle is inserted into the muscle to measure the response, as described above.
A neurologist receiving specialized training in clinical neurophysiology will do the electromyography procedure under the direct supervision of an experienced neurologist.
Read the detailed description
This is a training protocol to enable fellows in clinical neurophysiology to learn and perform technically advanced electrodiagnostic studies, such as single fiber EMG and macro EMG, on patients with neuromuscular diseases.
- Conditions
- Healthy, Neuromuscular Disease, Postpoliomyelitis Syndrome
- Being tested
- Electromyography
- Keywords
- Single Fiber EMG, Macro-EMG, Myasthenia, Post-Polio Syndrome, Neuromuscular Transmission, Motor Dysfunction, Neuromuscular Disorder
- Medical subject headings
- Neuromuscular Diseases, Postpoliomyelitis Syndrome, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectromyographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2000 (estimated)
- Study startFeb 2000
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004553
- Sponsor's protocol ID
- 000072
- Other IDs
- 00-N-0072
- Status last verified
- Nov 2005
- First submitted
- 4 Feb 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Sanders DB, Stalberg EV. AAEM minimonograph #25: single-fiber electromyography. Muscle Nerve. 1996 Sep;19(9):1069-83. doi: 10.1002/(SICI)1097-4598(199609)19:93.0.CO;2-Y.
PubMed 8761262Grimby G, Stalberg E, Sandberg A, Sunnerhagen KS. An 8-year longitudinal study of muscle strength, muscle fiber size, and dynamic electromyogram in individuals with late polio. Muscle Nerve. 1998 Nov;21(11):1428-37. doi: 10.1002/(sici)1097-4598(199811)21:113.0.co;2-x.
PubMed 9771666
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Neuromuscular Disorders With Specialized Electromyographic Studies
- ClinicalTrials.gov ID
- NCT00004553
- Acronym / sponsor ID
- 000072
- Conditions
- Healthy, Neuromuscular Disease, Postpoliomyelitis Syndrome
- Keywords
- Single Fiber EMG, Macro-EMG, Myasthenia, Post-Polio Syndrome, Neuromuscular Transmission, Motor Dysfunction, Neuromuscular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Feb 2000
- Study completion
- Nov 2005
- First posted
- 7 Feb 2000 (estimated)
- 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.
This study will investigate problems with muscle weakness and control using electromyography-a test of nerve-muscle cell communication. Advanced techniques called single fiber electromyography and macro-electromyography, which evaluate individual muscle fibers, will be used. Besides aiding in diagnosis, these tests provide information about disease progression that may be useful in guiding therapy.
Adult patients with suspected neurological disorders of muscle control and weakness may be eligible for this study. Normal volunteers may also participate. For the electromyography procedure, a special needle is inserted into a muscle. The patient will slightly tense the muscle and maintain the tension while electrical signals from the muscle fibers are being recorded. The electrical signals are played through a loudspeaker, providing feedback to help the patient tense the muscle the appropriate amount. The test, which is usually done for only one muscle, takes 1 to 2 hours. If needed, short breaks can be taken.
If the patient cannot maintain tension in the muscle for the entire test period, a nerve will be stimulated to activate the muscle. A thin needle is inserted near the nerve, and a series of small electrical shocks are given to activate a nerve fiber. The electromyography needle is inserted into the muscle to measure the response, as described above.
A neurologist receiving specialized training in clinical neurophysiology will do the electromyography procedure under the direct supervision of an experienced neurologist.
Detailed description
This is a training protocol to enable fellows in clinical neurophysiology to learn and perform technically advanced electrodiagnostic studies, such as single fiber EMG and macro EMG, on patients with neuromuscular diseases.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with weakness or motor dysfunction: 8/year.
- Normal volunteers, adults: 2/year.
Key exclusion criteria (2 listed)
- Anticoagulation or uncorrected bleeding disorder.
- Children are not optimal subjects for fellows undergoing training in these techniques and will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8761262Sanders DB, Stalberg EV. AAEM minimonograph #25: single-fiber electromyography. Muscle Nerve. 1996 Sep;19(9):1069-83. doi: 10.1002/(SICI)1097-4598(199609)19:93.0.CO;2-Y.
- Background: PubMed 9771666Grimby G, Stalberg E, Sandberg A, Sunnerhagen KS. An 8-year longitudinal study of muscle strength, muscle fiber size, and dynamic electromyogram in individuals with late polio. Muscle Nerve. 1998 Nov;21(11):1428-37. doi: 10.1002/(sici)1097-4598(199811)21:113.0.co;2-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyography in people with Healthy and Neuromuscular Disease, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Mar 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004553, which also lists 2 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 4 Mar 2008.