Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039819
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-06-11
Brief Title:
Nerve Stimulation to Modify a Spinal Reflex
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Plasticity of Reciprocal Inhibition
Status:
COMPLETED
Status Verified Date:
2003-05
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 study will determine whether stimulating the nerves or the brain can modify the spinal reflex that controls the muscles that flex and extend the ankle Training spinal nerve networks with sensory input may provide a way of re-establishing movements such as walking in patients with spinal injury
Healthy normal volunteers with no history of peripheral neuropathy or radiculopathy ankle contractures or tendon surgery may be eligible for this study Participants will undergo three stimulation procedures each in a different session to measure leg muscle reflexes The procedures are
Reflex testing - Metal electrodes are taped to the skin over the leg muscles A small electrical pulse is delivered through the electrodes to stimulate two nerves to the muscles This evokes a reflex between the ankle flexor and extensor muscles The responses to several dozen stimuli are averaged
Nerve stimulation - The nerve to the muscle that flexes the leg is electrically stimulated near the knee through electrodes taped to the skin The strength of the stimulus is adjusted to produce little or no muscle movement The stimulation is repeated every few seconds for 45 minutes
Transcranial magnetic stimulation - An insulated wire coil is placed on the subjects scalp A brief electrical current passes through the coil creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain There may be twitching in the muscles of the arm or leg During the stimulation the subject may be asked to tense certain muscles slightly or perform other simple actions to help determine the best position for the coil over the part of the brain that controls the leg The leg is then stimulated once every 10 seconds combined with nerve stimulation every 1 to 2 seconds
Healthy normal volunteers with no history of peripheral neuropathy or radiculopathy ankle contractures or tendon surgery may be eligible for this study Participants will undergo three stimulation procedures each in a different session to measure leg muscle reflexes The procedures are
Reflex testing - Metal electrodes are taped to the skin over the leg muscles A small electrical pulse is delivered through the electrodes to stimulate two nerves to the muscles This evokes a reflex between the ankle flexor and extensor muscles The responses to several dozen stimuli are averaged
Nerve stimulation - The nerve to the muscle that flexes the leg is electrically stimulated near the knee through electrodes taped to the skin The strength of the stimulus is adjusted to produce little or no muscle movement The stimulation is repeated every few seconds for 45 minutes
Transcranial magnetic stimulation - An insulated wire coil is placed on the subjects scalp A brief electrical current passes through the coil creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain There may be twitching in the muscles of the arm or leg During the stimulation the subject may be asked to tense certain muscles slightly or perform other simple actions to help determine the best position for the coil over the part of the brain that controls the leg The leg is then stimulated once every 10 seconds combined with nerve stimulation every 1 to 2 seconds
Detailed Description:
Training of spinal interneuronal networks may offer a means for re-establishing movements such as locomotion in patients with spinal injury Sensory feedback in the pattern which results from the leg movement is hypothesized to be the critical component for training spinal networks This protocol will address the basic assumption underlying such training can a specific pattern of sensory input modify the strength of a spinal cord circuit We will test whether peripheral nerve stimulation can modify the strength of the spinal reflex mediating reciprocal inhibition between ankle flexor and extensor muscles in normal subjects comparing patterned and unpatterned stimulation
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 |
|---|---|---|---|
| 02-N-0228 | None | None | None |