HealthyPhase 1NCT00055588
Nervous System Function in Normal Volunteers During Cycling Training
A Phase 1 study testing Locomotor training in people with Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will identify changes that occur in the nervous system of healthy normal volunteers while they are learning a cycling task. Healthy subjects 18 years of age and older who can cycle for 16 minutes may be eligible for this study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Locomotor training
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2003to 20 May 2008
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal volunteers (ages 18 and above) who are willing to participate and who are considered able to cycle for16 minutes based on neurological and physical exams.
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 cardiac pace-makers, intracardiac lines, or implanted medication pumps.
- Subjects with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system or disorders of the blood coagulation system.
- Subjects with eye, blood vessel, cochlear, or eye implants.
- Subjects with increased intracranial pressure as evaluated by clinical means.
- Subjects with metal in the cranium except in the mouth.
- Subjects with metal fragments from occupational exposure or surgical clips in or near the brain.
- Women in the last trimester of pregnancy.
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: Spinal Substrates of Training-Dependent Improvements in Locomotor Function
This study will identify changes that occur in the nervous system of healthy normal volunteers while they are learning a cycling task.
Healthy subjects 18 years of age and older who can cycle for 16 minutes may be eligible for this study. Candidates will be screened with a brief medical history and physical examination.
Read more
Participants will be assigned to one of three groups:
- Complex training: Cycling for 16 minutes at a constant speed of 60 rpm with frequent changes in pedal resistance.
- Simple training: Cycling for 16 minutes at a constant speed of 60 rpm with no changes in pedal resistance.
- No training: Remaining seated on the bike for 16 minutes performing no exercise.
Participants will cycle for 16 minutes for the training task, plus 4 minutes before and after the training. Reflexes will be measured with nerve conduction studies and somatosensory evoked potential (SSEP) recordings before and after training. Nerve conduction studies measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. For these studies, a probe is placed on the skin over the calf muscles and the knee to deliver a small electrical stimulus, and wires are taped to the skin to record the impulses. SSEP recordings, which measure of the excitability of the brain to sensory stimuli, are collected from electrodes placed on the scalp.
After the training period, multiple train stimulation (MTS) is applied for 10 minutes. For MTS, weak electrical currents are delivered for 10 seconds every 10 seconds. These stimuli produce a buzzing sensation without pain, discomfort, or muscle twitching. The MTS is followed by another 4 minutes of cycling.
Participants also undergo transcranial magnetic stimulation (TMS). For this procedure, an insulated wire coil is held over the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the brain cortex (outer part of the brain). The stimulation may cause twitching in the muscles of the face, arm, or leg. The electrical activity of the muscles is recorded with a computer or other recording device, using electrodes attached to the skin with tape.
Read the detailed description
In a previous study, we have shown that locomotor training with frequent changes in pedal resistances (complex training) elicits significant improvement in locomotor performance compared to training consisting of constant pedal resistance (simple training). Behavior gains associated with complex training correlate with down-regulation in the excitability of the alpha-motoneurone pools controlling muscles involved in the training task, as measured by changes in the soleus H-reflex, raising the hypothesis of a cause-effect link between performance improvements and modulation of spinal cord function. The purpose of this protocol is to determine if down-regulation in the excitability of the alpha-motoneuron pool is required for the improvement in locomotor performance. To address this issue, we hypothesize that up-regulation of alpha-motoneuron excitability will cancel improvements in locomotor performance elicited by complex training more than in subjects undergoing a period of simple training. The results of this study would provide novel information on the spinal substrates underlying learning of a locomotor task in intact humans and could be relevant to the design of rehabilitative strategies in patients with locomotor disorders.
- Conditions
- Healthy
- Being tested
- Locomotor training
- Keywords
- Spinal Reflexes, Motor Practice, Spinal Cord Injury, Locomotion, Healthy Volunteer, HV
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locomotor trainingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2003 (estimated)
- Study start4 Mar 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 60 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
- NCT00055588
- Sponsor's protocol ID
- 030120
- Other IDs
- 03-N-0120
- Status last verified
- 20 May 2008
- First submitted
- 6 Mar 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Boroojerdi B, Ziemann U, Chen R, Butefisch CM, Cohen LG. Mechanisms underlying human motor system plasticity. Muscle Nerve. 2001 May;24(5):602-13. doi: 10.1002/mus.1045.
PubMed 11317269
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
- Spinal Substrates of Training-Dependent Improvements in Locomotor Function
- ClinicalTrials.gov ID
- NCT00055588
- Acronym / sponsor ID
- 030120
- Conditions
- Healthy
- Keywords
- Spinal Reflexes, Motor Practice, Spinal Cord Injury, Locomotion, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 4 Mar 2003
- Study completion
- 20 May 2008
- First posted
- 6 Mar 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 identify changes that occur in the nervous system of healthy normal volunteers while they are learning a cycling task.
Healthy subjects 18 years of age and older who can cycle for 16 minutes may be eligible for this study. Candidates will be screened with a brief medical history and physical examination.
Participants will be assigned to one of three groups:
- Complex training: Cycling for 16 minutes at a constant speed of 60 rpm with frequent changes in pedal resistance.
- Simple training: Cycling for 16 minutes at a constant speed of 60 rpm with no changes in pedal resistance.
- No training: Remaining seated on the bike for 16 minutes performing no exercise.
Participants will cycle for 16 minutes for the training task, plus 4 minutes before and after the training. Reflexes will be measured with nerve conduction studies and somatosensory evoked potential (SSEP) recordings before and after training. Nerve conduction studies measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. For these studies, a probe is placed on the skin over the calf muscles and the knee to deliver a small electrical stimulus, and wires are taped to the skin to record the impulses. SSEP recordings, which measure of the excitability of the brain to sensory stimuli, are collected from electrodes placed on the scalp.
After the training period, multiple train stimulation (MTS) is applied for 10 minutes. For MTS, weak electrical currents are delivered for 10 seconds every 10 seconds. These stimuli produce a buzzing sensation without pain, discomfort, or muscle twitching. The MTS is followed by another 4 minutes of cycling.
Participants also undergo transcranial magnetic stimulation (TMS). For this procedure, an insulated wire coil is held over the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the brain cortex (outer part of the brain). The stimulation may cause twitching in the muscles of the face, arm, or leg. The electrical activity of the muscles is recorded with a computer or other recording device, using electrodes attached to the skin with tape.
Detailed description
In a previous study, we have shown that locomotor training with frequent changes in pedal resistances (complex training) elicits significant improvement in locomotor performance compared to training consisting of constant pedal resistance (simple training). Behavior gains associated with complex training correlate with down-regulation in the excitability of the alpha-motoneurone pools controlling muscles involved in the training task, as measured by changes in the soleus H-reflex, raising the hypothesis of a cause-effect link between performance improvements and modulation of spinal cord function. The purpose of this protocol is to determine if down-regulation in the excitability of the alpha-motoneuron pool is required for the improvement in locomotor performance. To address this issue, we hypothesize that up-regulation of alpha-motoneuron excitability will cancel improvements in locomotor performance elicited by complex training more than in subjects undergoing a period of simple training. The results of this study would provide novel information on the spinal substrates underlying learning of a locomotor task in intact humans and could be relevant to the design of rehabilitative strategies in patients with locomotor disorders.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal volunteers (ages 18 and above) who are willing to participate and who are considered able to cycle for16 minutes based on neurological and physical exams.
Key exclusion criteria (8 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 cardiac pace-makers, intracardiac lines, or implanted medication pumps.
- Subjects with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system or disorders of the blood coagulation system.
- Subjects with eye, blood vessel, cochlear, or eye implants.
- Subjects with increased intracranial pressure as evaluated by clinical means.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locomotor training | Procedure or surgery | – |
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 11317269Boroojerdi B, Ziemann U, Chen R, Butefisch CM, Cohen LG. Mechanisms underlying human motor system plasticity. Muscle Nerve. 2001 May;24(5):602-13. doi: 10.1002/mus.1045.
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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?
A Phase 1 study testing Locomotor training in people with 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 8 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00055588, 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.