Musculoskeletal PhysiologyNCT00132353
Training for Diagnosing Neurological Disorders
An observational study of Musculoskeletal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This training protocol has two objectives: 1) to train NINDS fellows in specialized techniques for diagnosing neurological disorders, and 2) to gather data from healthy volunteers and from patients with various disorders needed for tests to diagnose disorders of nerve, muscle, and the areas of the brain controlling… Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Physiology
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2005to 25 Jan 2021
- Phase
- Observational
- 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 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal volunteers and individuals with neurological disorders amenable to diagnosis through electrodiagnostic techniques.@@@@@@
Who may be able to join
- Adult patients, over age 18 years old, with a clinical indication for the diagnostic procedures will be enrolled
- Suspected disorders of neuromuscular transmission, such as myasthenia gravis or
- Suspected Central demyelinating disorders such as multiple sclerosis or
- Suspected Myelopathy or
- Suspected motor neuron disease or
- Suspected Movement disorders that impair intracortical processes or
Show all 9Show fewer
- Suspected neuropathy or myopathy or
- Suspected autonomic dysfunction
- Healthy adults, aged 18 years or older, willing to participate
Who cannot join
- Patients with implanted devices, such as pacemakers, or metal in the cranium (excluding dental work) will be excluded from magnetic stimulation studies.
- Children under age 18 will be excluded, since the goal of this protocol is to provide training experience.
- Subjects who are unable to provide informed consent
- Persons undergoing the autonomic testing will be asked to refrain from smoking, caffeine, alcohol and vigorous exercise 24 hours before the study. Several medications should not be taken 48 hours prior to the study; these include tricyclic antidepressants, antihistamines, cough and cold medications, anti-Parkinson medication, muscle relaxants, anti-psychosis medications, opioid drugs, and blood pressure medications. No one is to stop their prescribed medication without discussion with their primary care physician though the ability to complete all of the autonomic testing may be affected.
- Medical conditions that require medications that affect the physiological measures being tested
- History of stroke, peripheral neuropathy or spine surgery
Show all 9Show fewer
- Implanted devices or metal in the cranium (except dental work) if undergoing magnetic stimulation
- Persons undergoing the autonomic testing will be asked to refrain from smoking, caffeine, alcohol and vigorous exercise 24 hours before the study. Several medications should not be taken 48 hours prior to the study; these include tricyclic antidepressants, antihistamines, cough and cold medications, anti-Parkinson's medication, muscle relaxants, anti-psychosis medications, opioid drugs, and blood pressure medications. No one is to stop their prescribed medication without discussion with their primary care physician and you may be excluded from the study.
- NIH employees and staff may participate, except if they are EMG Section, OCD, NINDS employees.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Clinical Neurophysiology: Training and Normative Values
This training protocol has two objectives: 1) to train NINDS fellows in specialized techniques for diagnosing neurological disorders, and 2) to gather data from healthy volunteers and from patients with various disorders needed for tests to diagnose disorders of nerve, muscle, and the areas of the brain controlling movement.
Healthy volunteers and patients with neurological disorders of nerve and muscle who require specialized diagnostic testing may be eligible for this study. Candidates must be 18 years of age or older. They are screened with a medical history and neurological examination.
Read more
Immediately after screening, participants undergo one or two of the following tests:
- Transcranial magnetic stimulation: This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. During the stimulation, electrical activity of muscles is recorded with a computer, using electrodes (small metal disks) attached to the skin with tape.
- Electromyography (EMG): This test measures the electrical activity of muscles and is used to diagnose problems with the nerves or muscles. For surface EMG, electrodes are filed with a conductive gel and taped to the skin. Needle EMG involves inserting a needle into a muscle to record the electrical activity. Single fiber EMG uses specialized needles that allow recording from single muscle fibers. The needle is inserted into a muscle and the subject is asked to tense that muscle slightly.
- Nerve conduction study: This test measures the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. It is done by taping wires on the skin to record the impulses and placing a probe on the skin to deliver a small electrical stimulus.
- Near-nerve recording: This test is a nerve conduction study that is used to measure responses from very small nerves. It uses a needle placed under the skin to record the nerve response.
- Quantitative sensory testing: This test measures how well the subject feels vibration and cold. A probe that can vibrate or cool down is attached to the subject's finger or foot. The subject presses a button when he or she feels the stimulus. A computer adjusts the intensity of the stimulus to find the lowest level the subject can feel.
- Nerve ultrasound: This test uses sound waves to examine the nerves. Warm gel is applied to the skin and a probe is held on the skin surface.
Read the detailed description
Objective: This is a training protocol. The goal of this protocol is to train fellows in advanced physiological techniques used for diagnosing neurological disorders. A secondary objective of the protocol is to gather normative data for diagnostic neurophysiologic tests.
Study population: Patients and healthy adult volunteers may be studied under this protocol. Patients must have a clinical indication for the diagnostic test. Most patients will be enrolled in a primary NIH protocol, and this protocol will serve as a secondary protocol. Occasionally, patients will be enrolled in this protocol as a primary protocol when they are referred from hospitals that participate in the NINDS fellowship training program. Healthy adults will be studied by fellows-in-training to practice a new testing procedure or to provide normative data when required by changes in instrumentation or laboratory technique.
Design: Testing will be performed during an outpatient clinic visit. One or two of the following procedures may be performed as clinically indicated: single fiber EMG, macro-EMG, near-nerve recording, single-pulse transcranial or peripheral nerve magnetic stimulation, quantitative sensory testing, nerve conduction studies, electromyography, nerve ultrasonography, or autonomic testing.
Outcome measures: This is a training protocol. No research will be carried out under this protocol.
- Conditions
- Musculoskeletal Physiology
- Keywords
- Magnetic Stimulation, Single Fiber EMG, Ultrasonography, Autonomic Testing, Near-nerve recording
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 |
|---|---|---|
| Healthy volunteers | For normative data | |
| Patients with neurological disorders | For teaching fellows electrodiagnostic techniques |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study start4 Nov 2005
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PhysiologyStudies of the same condition, open and under way.
- 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- 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
- NCT00132353
- Sponsor's protocol ID
- 050223
- Other IDs
- 05-N-0223
- Status last verified
- Jan 2021
- First submitted
- 18 Aug 2005
- Last updated
- 26 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Neurophysiology: Training and Normative Values
- ClinicalTrials.gov ID
- NCT00132353
- Acronym / sponsor ID
- 050223
- Conditions
- Musculoskeletal Physiology
- Keywords
- Magnetic Stimulation, Single Fiber EMG, Ultrasonography, Autonomic Testing, Near-nerve recording
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 4 Nov 2005 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 19 Aug 2005 (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 training protocol has two objectives: 1) to train NINDS fellows in specialized techniques for diagnosing neurological disorders, and 2) to gather data from healthy volunteers and from patients with various disorders needed for tests to diagnose disorders of nerve, muscle, and the areas of the brain controlling movement.
Healthy volunteers and patients with neurological disorders of nerve and muscle who require specialized diagnostic testing may be eligible for this study. Candidates must be 18 years of age or older. They are screened with a medical history and neurological examination.
Immediately after screening, participants undergo one or two of the following tests:
- Transcranial magnetic stimulation: This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. During the stimulation, electrical activity of muscles is recorded with a computer, using electrodes (small metal disks) attached to the skin with tape.
- Electromyography (EMG): This test measures the electrical activity of muscles and is used to diagnose problems with the nerves or muscles. For surface EMG, electrodes are filed with a conductive gel and taped to the skin. Needle EMG involves inserting a needle into a muscle to record the electrical activity. Single fiber EMG uses specialized needles that allow recording from single muscle fibers. The needle is inserted into a muscle and the subject is asked to tense that muscle slightly.
- Nerve conduction study: This test measures the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. It is done by taping wires on the skin to record the impulses and placing a probe on the skin to deliver a small electrical stimulus.
- Near-nerve recording: This test is a nerve conduction study that is used to measure responses from very small nerves. It uses a needle placed under the skin to record the nerve response.
- Quantitative sensory testing: This test measures how well the subject feels vibration and cold. A probe that can vibrate or cool down is attached to the subject's finger or foot. The subject presses a button when he or she feels the stimulus. A computer adjusts the intensity of the stimulus to find the lowest level the subject can feel.
- Nerve ultrasound: This test uses sound waves to examine the nerves. Warm gel is applied to the skin and a probe is held on the skin surface.
Detailed description
Objective: This is a training protocol. The goal of this protocol is to train fellows in advanced physiological techniques used for diagnosing neurological disorders. A secondary objective of the protocol is to gather normative data for diagnostic neurophysiologic tests.
Study population: Patients and healthy adult volunteers may be studied under this protocol. Patients must have a clinical indication for the diagnostic test. Most patients will be enrolled in a primary NIH protocol, and this protocol will serve as a secondary protocol. Occasionally, patients will be enrolled in this protocol as a primary protocol when they are referred from hospitals that participate in the NINDS fellowship training program. Healthy adults will be studied by fellows-in-training to practice a new testing procedure or to provide normative data when required by changes in instrumentation or laboratory technique.
Design: Testing will be performed during an outpatient clinic visit. One or two of the following procedures may be performed as clinically indicated: single fiber EMG, macro-EMG, near-nerve recording, single-pulse transcranial or peripheral nerve magnetic stimulation, quantitative sensory testing, nerve conduction studies, electromyography, nerve ultrasonography, or autonomic testing.
Outcome measures: This is a training protocol. No research will be carried out under this protocol.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –For normative data |
| Patients with neurological disorders | – | –For teaching fellows electrodiagnostic techniques |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal volunteers and individuals with neurological disorders amenable to diagnosis through electrodiagnostic techniques.@@@@@@
Key inclusion criteria (9 listed)
- Adult patients, over age 18 years old, with a clinical indication for the diagnostic procedures will be enrolled
- Suspected disorders of neuromuscular transmission, such as myasthenia gravis or
- Suspected Central demyelinating disorders such as multiple sclerosis or
- Suspected Myelopathy or
- Suspected motor neuron disease or
Key exclusion criteria (9 listed)
- Patients with implanted devices, such as pacemakers, or metal in the cranium (excluding dental work) will be excluded from magnetic stimulation studies.
- Children under age 18 will be excluded, since the goal of this protocol is to provide training experience.
- Subjects who are unable to provide informed consent
- Persons undergoing the autonomic testing will be asked to refrain from smoking, caffeine, alcohol and vigorous exercise 24 hours before the study. Several medications should not be taken 48 hours prior to the study; these include tricyclic antidepressants, antihistamines, cough and cold medications, anti-Parkinson medication, muscle relaxants, anti-psychosis medications, opioid drugs, and blood pressure medications. No one is to stop their prescribed medication without discussion with their primary care physician though the ability to complete all of the autonomic testing may be affected.
- Medical conditions that require medications that affect the physiological measures being tested
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
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 26 Jan 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
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 Musculoskeletal Physiology, 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 9 inclusion and 9 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 26 Jan 2021. 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?
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 26 Jan 2021.