Transcutaneous Spinal Stimulation and Exercise for Locomotion

Study Overview
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Brief Summary
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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.

Official Title
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Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Transcutaneous spinal stimulation
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcutaneous spinal stimulation & Physical therapy<br>Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions | Device: Transcutaneous spinal stimulation<br>* Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions<br>* Other names: Physical Therapy;Other: Physical Therapy<br>* physical therapy to improve walking and standing functions<br>|
| Active Comparator: Physical therapy only<br>Physical therapy that targets rehabilitation of walking and standing functions | Other: Physical Therapy<br>* physical therapy to improve walking and standing functions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walk Test | Measurement of walking ability. The distance is reported in meter. | 8-11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination | Standard neurologic examination that is routinely used to determine the levels and severity of spinal cord injury. Includes manual muscle strength testing and dermatomal light touch and pin prick sensory examination. | 8-11 months | 
| Somatosensory evoked potentials | Measurement of latency of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The latency of the response is reported in micro-seconds. | 8-11 months | 
| Somatosensory evoked potentials | Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The amplitude of the response is reported in micro-volts. | 8-11 months | 
| Motor evoked potentials | Measurement of latency of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The latency of the response is reported in micro-seconds. | 8-11 months | 
| Motor evoked potentials | Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The amplitude of the response is reported in micro-volts. | 8-11 months | 
| Berg Balance Test | Measurement of balance in standing and sitting. The balance score consists of 14 items and is reported in the scale of 56 (each items are score in 0-4). | 8-11 months | 
| Ten-minute walk test | Measurement of walking ability. The walking speed is reported in meter per second. | 8-11 months | 
| Kinetic and kinematic gait analysis using 3D camera system | Measurement of leg function and walking ability. Joint angle is reported in degree angle. | 8-11 months | 
| Kinetic and kinematic gait analysis using 3D camera system | Measurement of leg function and walking ability. Velocity is reported in meter per second. | 8-11 months | 
| Electromyography recording of lower extremity and trunk muscles | Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts. | 8-11 months | 
| Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire | Patient reported quality of life scale. The SCI-QOL consists of 19 item banks, and is reported by T-score comparing the mean of the functional level in the population. | 8-11 months | 
| Spinal Cord Injury - Functional Index (SCI-FI) questionnaire | Patient reported functional scale. The SCI-QOL consists of 10 item banks, and is reported by T-score comparing the mean of the functional level in the population. | 8-11 months | 
| Modified Ashworth Scale | Measurement of spasticity. Tests resistance to passive movement about joints. Score range from 0-4, with 6 choices. | 8-11 months | 
| Neurogenic Bowel Dysfunction Score | self-report questionnaire designed to help healthcare professionals evaluate the effectiveness of their patient's current bowel management routine by assessing the impact it has on the patient's quality of life. Questions ask about background parameters (n=8), faecal incontinence (n=10), constipation (n=10), obstructed defecation (n=8), and impact on quality of life (QOL). | 8-11 months | 
| Neurogenic Bladder Symptom Score | objective and validated self-report questionnaire to assess bladder symptoms in patients with neurogenic bladder dysfunction. | 8-11 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal electrical stimulation