HealthyNCT00039819
Nerve Stimulation to Modify a Spinal Reflex
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to May 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy adult volunteers willing to participate
Who cannot join
- History of peripheral neuropathy or radiculopathy
- Implanted devices, including pacemakers, pumps, and defibrillators
- Ankle contractures or tendon surgery
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: Plasticity of Reciprocal Inhibition
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 subject's 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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Spinal Cord, Sensory Stimulation, Locomotion, Magnetic Stimulation, Reflexes, Healthy Volunteer, HV, Normal Control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2002 (estimated)
- Study startJun 2002
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039819
- Sponsor's protocol ID
- 020228
- Other IDs
- 02-N-0228
- Status last verified
- May 2003
- First submitted
- 11 Jun 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Burke RE. The central pattern generator for locomotion in mammals. Adv Neurol. 2001;87:11-24. No abstract available.
PubMed 11347213Wirz M, Colombo G, Dietz V. Long term effects of locomotor training in spinal humans. J Neurol Neurosurg Psychiatry. 2001 Jul;71(1):93-6. doi: 10.1136/jnnp.71.1.93.
PubMed 11413270Rossignol S. Locomotion and its recovery after spinal injury. Curr Opin Neurobiol. 2000 Dec;10(6):708-16. doi: 10.1016/s0959-4388(00)00151-3.
PubMed 11240279
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
- Plasticity of Reciprocal Inhibition
- ClinicalTrials.gov ID
- NCT00039819
- Acronym / sponsor ID
- 020228
- Conditions
- Healthy
- Keywords
- Spinal Cord, Sensory Stimulation, Locomotion, Magnetic Stimulation, Reflexes, Healthy Volunteer, HV, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 2002
- Study completion
- May 2003
- First posted
- 12 Jun 2002 (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 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 subject's 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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult volunteers willing to participate
Key exclusion criteria (3 listed)
- History of peripheral neuropathy or radiculopathy
- Implanted devices, including pacemakers, pumps, and defibrillators
- Ankle contractures or tendon surgery
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 4 Mar 2008.
- Background: PubMed 11347213Burke RE. The central pattern generator for locomotion in mammals. Adv Neurol. 2001;87:11-24. No abstract available.
- Background: PubMed 11413270Wirz M, Colombo G, Dietz V. Long term effects of locomotor training in spinal humans. J Neurol Neurosurg Psychiatry. 2001 Jul;71(1):93-6. doi: 10.1136/jnnp.71.1.93.
- Background: PubMed 11240279Rossignol S. Locomotion and its recovery after spinal injury. Curr Opin Neurobiol. 2000 Dec;10(6):708-16. doi: 10.1016/s0959-4388(00)00151-3.
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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?
An observational study of Healthy, 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 1 inclusion and 3 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 NCT00039819, which also lists 3 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.