Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055588
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-03-06
Brief Title:
Nervous System Function in Normal Volunteers During Cycling Training
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Spinal Substrates of Training-Dependent Improvements in Locomotor Function
Status:
COMPLETED
Status Verified Date:
2008-05-20
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 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
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 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 |
|---|---|---|---|
| 03-N-0120 | None | None | None |