Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2003

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2003

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2008

Completed
Last Updated

July 2, 2017

Status Verified

May 20, 2008

First QC Date

December 1, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

Spinal ReflexesLocomotionMotor PracticeHealthy VolunteerHV

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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.

    PMID: 7820579BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 1, 2003

First Posted

December 2, 2003

Study Start

December 1, 2003

Study Completion

May 20, 2008

Last Updated

July 2, 2017

Record last verified: 2008-05-20

Locations