The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual. In this study 10 subjects, more than 1 year post injury, will be enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in the rehabilitation of the legs of participants with incomplete SCI.

Eligibility Criteria:

Inclusion Criteria: - Paraplegia or tetraplegia due to SCI - At least 1 year post incomplete Spinal Cord Injury - Can tolerate sitting upright for at least one hour - Capable of weight-bearing and taking a step with or without an assistive device - On the ASIA sensory function (light touch), a score of at least 1 at the L4 and L5 level - Primary ASIA Motor Criterion (PAMC) a total score of 4-12 for hip extensors, knee extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for each of these muscles in the qualifying leg Exclusion Criteria: - Fracture of the treated limb resulting in loss of range of motion - Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study), or other neurological injury or disease - DVT of the treated extremity - Peripheral nerve injury of the treated extremity - Osteo- or rheumatoid-arthritis limiting range of motion - Contractures equal to or greater than 50% of the normal ROM - Skin condition not tolerant of device or sitting upright - Progressive neurodegenerative disorder - Botox treatment of the treated extremity in the prior 5 month - Chronic ITB therapy - Uncontrolled seizure disorder - Uncontrolled high blood pressure/angina - Pain in affected limb or exercise intolerance - Participation in another therapy or activity-based program - Combined score on ASIA motor function for knee extensors, ankle dorsiflexors and ankle plantarflexors outside the range of 3-9

Study Design:

Study Location:

Multiple U.S. Locations