HealthyNCT00073606
Spinal Cord Plasticity
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 examine the role of the spinal cord in improving leg movements after physical training in healthy people. The results of this study may be helpful in developing new rehabilitation therapies for people with impaired leg function. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Healthy
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2003to 20 May 2008
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy volunteers (age 21 to 65 years) who are willing to participate and who are considered able to cylce for 16 minutes based on neurological and physical exams will be eligible for the study. Reproductive age women with a negative pregnancy test.
Who cannot join
- Subjects with history of heart condition, unresponsive arterial hypertension, diabetes, chronic back pain, sciatica, peripheral neuropathy, rheumatoid arthritis, active joint deformity of arthritic origin, alcohol or drug abuse, psychiatric disorder requiring hospitalization or prolonged treatment, head injury with loss of consciousness, epilepsy. Subjects with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system or disorders of the blood coagulation system. Pregnant women.
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: Intraspinal Plasticity Associated With Locomotor Learning
This study will examine the role of the spinal cord in improving leg movements after physical training in healthy people. The results of this study may be helpful in developing new rehabilitation therapies for people with impaired leg function.
Healthy volunteers between 21 and 65 years of age may be eligible for this study. Candidates will be screened with a brief medical history and physical examination.
Read more
Participants will undergo EMG-H reflex measurement while pedaling on a stationary bicycle. For this test, the subject is given an electrical stimulation at the nerve at the back of the knee while pedaling on a stationary bicycle. The shock produces a jerky movement called the "H reflex." The muscular activity causing these reflexes is measured using electrodes (small metal disks) filled with a conductive gel and taped to the skin over the calf muscle. The nerve is stimulated at four different frequencies during the experiment. While cycling, pedal resistance changes, making it harder or easier to pedal.
On study day 1, participants have EMG-H reflex measurement to determine baseline performance, then a training session to prepare for the actual test, and then a post-training test to measure performance again. The test is repeated on days 2, then between days 5 and 8, and again between days 11 and 14. The screening and first visit last 2 hours; the remaining test visits are 1 hour each. The bicycling time is only 15 minutes during training and 5 minutes at each test session.
Read the detailed description
Objectives
We aim to determine whether the development of a motor memory in the human spinal cord circuitry (expressed as a down regulation of the monosynaptic soleus H reflex) after a brief period of learning of a locomotor skill, is intrinsically encoded at the spinal cord level or if it is determined by descending suprasegmental influences.
The results of this study would be useful for designing new rehabilitation strategies based upon manipulation of peripheral inputs aimed at activating spinal cord circuitry for motor recovery independent of the higher centers.
Study population
Seventy (70) healthy volunteers (median age 21-65) will participate in the study.
Design
Subjects will complete one training session (using a recumbent cycle ergometer) and will be tested physiologically and behaviorally once before training and four times after training through 14 to 16 days.
Outcome measures
We will assess homosynaptic depression of the soleus H reflex (an expression of the excitability of the alpha-motorneuron pool), a phenomenon that is not susceptible to descending suprasegmental influences but depends on the history of information arriving to the alpha-motorneuron from the periphery. Amount of homosynaptic depression will be correlated with the behavioral learning assessed by improvement in control of stepping speed.
- Conditions
- Healthy
- Keywords
- Spinal Reflexes, Locomotion, Motor Practice, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2003 (estimated)
- Study start1 Dec 2003
- Study completion20 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 70 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
- NCT00073606
- Sponsor's protocol ID
- 040054
- Other IDs
- 04-N-0054
- Status last verified
- 20 May 2008
- First submitted
- 1 Dec 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Faist M, Mazevet D, Dietz V, Pierrot-Deseilligny E. A quantitative assessment of presynaptic inhibition of Ia afferents in spastics. Differences in hemiplegics and paraplegics. Brain. 1994 Dec;117 ( Pt 6):1449-55. doi: 10.1093/brain/117.6.1449.
PubMed 7820579
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraspinal Plasticity Associated With Locomotor Learning
- ClinicalTrials.gov ID
- NCT00073606
- Acronym / sponsor ID
- 040054
- Conditions
- Healthy
- Keywords
- Spinal Reflexes, Locomotion, Motor Practice, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Dec 2003
- Study completion
- 20 May 2008
- First posted
- 2 Dec 2003 (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 examine the role of the spinal cord in improving leg movements after physical training in healthy people. The results of this study may be helpful in developing new rehabilitation therapies for people with impaired leg function.
Healthy volunteers between 21 and 65 years of age may be eligible for this study. Candidates will be screened with a brief medical history and physical examination.
Participants will undergo EMG-H reflex measurement while pedaling on a stationary bicycle. For this test, the subject is given an electrical stimulation at the nerve at the back of the knee while pedaling on a stationary bicycle. The shock produces a jerky movement called the "H reflex." The muscular activity causing these reflexes is measured using electrodes (small metal disks) filled with a conductive gel and taped to the skin over the calf muscle. The nerve is stimulated at four different frequencies during the experiment. While cycling, pedal resistance changes, making it harder or easier to pedal.
On study day 1, participants have EMG-H reflex measurement to determine baseline performance, then a training session to prepare for the actual test, and then a post-training test to measure performance again. The test is repeated on days 2, then between days 5 and 8, and again between days 11 and 14. The screening and first visit last 2 hours; the remaining test visits are 1 hour each. The bicycling time is only 15 minutes during training and 5 minutes at each test session.
Detailed description
Objectives
We aim to determine whether the development of a motor memory in the human spinal cord circuitry (expressed as a down regulation of the monosynaptic soleus H reflex) after a brief period of learning of a locomotor skill, is intrinsically encoded at the spinal cord level or if it is determined by descending suprasegmental influences.
The results of this study would be useful for designing new rehabilitation strategies based upon manipulation of peripheral inputs aimed at activating spinal cord circuitry for motor recovery independent of the higher centers.
Study population
Seventy (70) healthy volunteers (median age 21-65) will participate in the study.
Design
Subjects will complete one training session (using a recumbent cycle ergometer) and will be tested physiologically and behaviorally once before training and four times after training through 14 to 16 days.
Outcome measures
We will assess homosynaptic depression of the soleus H reflex (an expression of the excitability of the alpha-motorneuron pool), a phenomenon that is not susceptible to descending suprasegmental influences but depends on the history of information arriving to the alpha-motorneuron from the periphery. Amount of homosynaptic depression will be correlated with the behavioral learning assessed by improvement in control of stepping speed.
Study design
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers (age 21 to 65 years) who are willing to participate and who are considered able to cylce for 16 minutes based on neurological and physical exams will be eligible for the study. Reproductive age women with a negative pregnancy test.
Key exclusion criteria (1 listed)
- Subjects with history of heart condition, unresponsive arterial hypertension, diabetes, chronic back pain, sciatica, peripheral neuropathy, rheumatoid arthritis, active joint deformity of arthritic origin, alcohol or drug abuse, psychiatric disorder requiring hospitalization or prolonged treatment, head injury with loss of consciousness, epilepsy. Subjects with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system or disorders of the blood coagulation system. Pregnant women.
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 2 Jul 2017.
- Background: PubMed 7820579Faist M, Mazevet D, Dietz V, Pierrot-Deseilligny E. A quantitative assessment of presynaptic inhibition of Ia afferents in spastics. Differences in hemiplegics and paraplegics. Brain. 1994 Dec;117 ( Pt 6):1449-55. doi: 10.1093/brain/117.6.1449.
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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 1 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 2 Jul 2017. 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 NCT00073606, which also lists 1 linked publication.
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 2 Jul 2017; AzTrials last refreshed its copy on 30 Oct 2026.