Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132353
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2005-08-18
Brief Title:
Training for Diagnosing Neurological Disorders
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Neurophysiology Training and Normative Values
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 subjects 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
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 subjects 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-N-0223 | None | None | None |