Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University of Washington
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Six-Minute Walk Test
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated, and painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be effective in improving lower limb motor function in participants with spinal cord injury. Our current project, cervical transcutaneous electrical stimulation and intensive exercise for arms and hands are also revealing a significant improvement in upper extremity function. Additionally, the subject and caregiver noted that stair climbing ability has been substantially enhanced starting from the first week of cervical stimulation treatment and continues to date.
This study is a prospective efficacy trial of combined transcutaneous cervical and lumbosacral electrical stimulation with physical therapy for improving locomotion in people with anatomically incomplete tetraplegia and paraplegia.
This experiment design consists of testing walking function with and without transcutaneous spinal cord stimulation. A two to four-phase intervention program will include physical therapy and spinal cord stimulation with physical therapy. The length of any intervention phase, and number of measurements performed during that phase, will be determined by multiple factors, including participants' health condition, availability, and response to intervention. Between each intervention, washout periods of up to one month may be used to determine any after-effects of the interventions.
The intervention arms will be repeated if the functional improvement does not reach a plateau during the first two months of intervention. Physical therapy will include functional training (e.g., walking training) and strength training. Each spinal cord stimulation with physical therapy intervention block can use transcutaneous lumbosacral stimulation or cervical and lumbosacral stimulation. Both immediate and lasting improvements in lower extremity function and autonomic function via transcutaneous spinal cord stimulation and intensive physical therapy may be evaluated.
Investigators
Chet Moritz
Associate Professor
University of Washington
Eligibility Criteria
Inclusion Criteria
- •Has spinal cord injury (T12 or higher level) of at least 1-year duration
- •Is between 21 and 70 years of age
- •Has difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing)
- •Has stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities
- •Is capable of performing simple cued motor tasks
- •Has ability to attend up to 5 sessions per week physical therapy sessions and testing activities
- •Has adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period
- •Is volunteering to be involved in this study
- •Cleared for gait training by the primary physician of the subject
- •Has the ability to read and speak English
Exclusion Criteria
- •Has autoimmune etiology of spinal cord dysfunction/injury
- •Has history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
- •Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- •Has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- •Has significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
- •Has active cancer
- •Has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- •Has unhealed fracture, contracture, pressure sore, urinary tract infection, or other illnesses that might interfere with lower extremity rehabilitation or testing activities
- •Has any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
- •is pregnant
Outcomes
Primary Outcomes
Six-Minute Walk Test
Time Frame: 1-11 months
Measurement of walking ability. The distance is reported in meter.
Two-minute walk test
Time Frame: 1-11 months
A measurement of endurance that assesses walking distance over two minutes.
Secondary Outcomes
- Kinetic and kinematic gait analysis using 3D camera system(1-11 months)
- Electromyography recording of lower extremity and trunk muscles(1-11 months)
- Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire(1-11 months)
- Spinal Cord Injury - Functional Index (SCI-FI) questionnaire(1-11 months)
- Modified Ashworth Scale(1-11 months)
- Neurogenic Bowel Dysfunction Score(1-11 months)
- Neurogenic Bladder Symptom Score(1-11 months)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination(1-11 months)
- Somatosensory evoked potentials(1-11 months)
- Motor evoked potentials(1-11 months)
- Berg Balance Test(1-11 months)
- Ten-meter walk test(1-11 months)
- Gait analysis(1-11 months)