Transcutaneous Spinal Stimulation and Exercise for Locomotion
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 4/28/2018 |
| Start Date: | February 28, 2018 |
| End Date: | August 31, 2020 |
| Contact: | Soshi Samejima, DPT, MS |
| Email: | soshis@uw.edu |
| Phone: | 206 221-8961 |
Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion
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 for 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, is also revealing significant improvement of 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 intensive physical therapy for improving locomotion
in people with incomplete tetraplegia and paraplegia.
This experiment design consists of two to four phase intervention program including one-month
physical therapy (PT) only (A) followed by one-month spinal stimulation with PT (B). Between
each intervention, washout periods of up to one-month may be used to determine any
after-effect of the interventions. The AB or BA interventions will be repeated if the
functional improvement does not reach a plateau during the first two month of interventions.
Sessions will last up to 2 hours/day, 2 to 5 days/week for each arm. Both immediate and
lasting improvements in lower extremity function and autonomic function via transcutaneous
spinal stimulation and intensive physical therapy will be evaluated.
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 for 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, is also revealing significant improvement of 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 intensive physical therapy for improving locomotion
in people with incomplete tetraplegia and paraplegia.
This experiment design consists of two to four phase intervention program including one-month
physical therapy (PT) only (A) followed by one-month spinal stimulation with PT (B). Between
each intervention, washout periods of up to one-month may be used to determine any
after-effect of the interventions. The AB or BA interventions will be repeated if the
functional improvement does not reach a plateau during the first two month of interventions.
Sessions will last up to 2 hours/day, 2 to 5 days/week for each arm. Both immediate and
lasting improvements in lower extremity function and autonomic function via transcutaneous
spinal stimulation and intensive physical therapy will be evaluated.
Inclusion Criteria:
- Has spinal cord injury (T12 or higher level) 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 primary physician of the subject
- Has 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, MS, 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, or 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
- is dependent on ventilation support
- Has implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker,
cochlear implant, etc).
- Has depression or anxiety based on the Center for Epidemiologic Studies Depression
Scale (CESD) (score >16/60) and General Anxiety Disorder-7 item Questionnaire (score
>9/21), respectively.
- Has alcohol and/or drug abuse.
- Has cognitive impairment based on Short Portable Mental Status Questionnaire (SPMSQ)
(score >2/10).
- is unable to read and/or comprehend the consent form.
- is unable to understand the instructions given as part of the study
- Has established osteoporosis and taking medication for osteoporosis treatment.
- Has bone mineral density T scores ≤ -2.0 in anteroposterior lumbar spine and/or
proximal femur measured by DEXA (if participants are clear for other criteria and have
not been examined by DEXA at the screening, we will ask participants to undergo DEXA
to reveal any risk of weight bearing activity)
- Has low-energy fracture history before or after spinal cord injury
We found this trial at
1
site
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Chet Moritz, PhD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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