Clinical trial NCT03509558: Transcutaneous Spinal Stimulation and Exercise for Locomotion
Official title: Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal electrical stimulation
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 intensive physical therapy for improving locomotion in people with incomplete tetraplegia and paraplegia.

This experiment design consists of two to four-phase intervention programs, including one-month physical therapy only followed by one-month spinal stimulation combined with physical therapy. 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 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.


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
* 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 ≤ -3.5 in the anteroposterior lumbar spine and/or proximal femur measured by DEXA (if participants are clear for other criteria and have not been examined by Dual Energy Xray Absorptiometry (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

Primary outcomes:
measure: Six-Minute Walk Test
timeFrame: 8-11 months
Secondary outcomes:
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
timeFrame: 8-11 months
measure: Somatosensory evoked potentials
timeFrame: 8-11 months
measure: Somatosensory evoked potentials
timeFrame: 8-11 months
measure: Motor evoked potentials
timeFrame: 8-11 months
measure: Motor evoked potentials
timeFrame: 8-11 months
measure: Berg Balance Test
timeFrame: 8-11 months
measure: Ten-minute walk test
timeFrame: 8-11 months
measure: Kinetic and kinematic gait analysis using 3D camera system
timeFrame: 8-11 months
measure: Kinetic and kinematic gait analysis using 3D camera system
timeFrame: 8-11 months
measure: Electromyography recording of lower extremity and trunk muscles
timeFrame: 8-11 months
measure: Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire
timeFrame: 8-11 months
measure: Spinal Cord Injury - Functional Index (SCI-FI) questionnaire
timeFrame: 8-11 months
measure: Modified Ashworth Scale
timeFrame: 8-11 months
measure: Neurogenic Bowel Dysfunction Score
timeFrame: 8-11 months
measure: Neurogenic Bladder Symptom Score
timeFrame: 8-11 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: