Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 10/26/2018 |
| Start Date: | December 27, 2016 |
| End Date: | June 2020 |
| Contact: | Fatma Inanici, MD |
| Email: | finanici@uw.edu |
| Phone: | 206 787-2692 |
Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
Stimulation of the spinal cord may induce the growth and reorganization of neural pathways
leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical
spinal cord stimulation improves motor functions immediately via modulating the excitability
of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive,
well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated
to be effective for improving lower limb motor function in healthy individuals and in
patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical
electrical stimulation can enhance conscious motor control and functions of hand and arm via
neuromodulation of spinal network.
This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation
for improving upper limb function in patients with traumatic or degenerative cervical spinal
cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the
United States Food and Drug Administration for treatment of spinal cord injury.
The interventions include either transcutaneous cervical spinal electrical stimulation
combined with physical therapy or physical therapy only. The order of the interventions will
be randomized for each subject in a delayed cross-over design. Total duration of the study is
6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks
follow-up. Both immediate and lasting improvements in hand motor and sensory function via
transcutaneous cervical spinal stimulation will be evaluated.
leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical
spinal cord stimulation improves motor functions immediately via modulating the excitability
of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive,
well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated
to be effective for improving lower limb motor function in healthy individuals and in
patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical
electrical stimulation can enhance conscious motor control and functions of hand and arm via
neuromodulation of spinal network.
This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation
for improving upper limb function in patients with traumatic or degenerative cervical spinal
cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the
United States Food and Drug Administration for treatment of spinal cord injury.
The interventions include either transcutaneous cervical spinal electrical stimulation
combined with physical therapy or physical therapy only. The order of the interventions will
be randomized for each subject in a delayed cross-over design. Total duration of the study is
6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks
follow-up. Both immediate and lasting improvements in hand motor and sensory function via
transcutaneous cervical spinal stimulation will be evaluated.
Inclusion Criteria:
- Cervical (C7 or higher) spinal cord injury at least 1 year duration
- Between 21 and 70 years of age
- Difficulty with hand functions in activities of daily living (e.g. dressing, grooming,
feeding)
- Stable medical condition without cardiopulmonary disease or frequent autonomic
dysreflexia that would contraindicate participation in upper extremity rehabilitation
or testing activities
- Capable of performing simple cued motor tasks
- Ability to attend 2 to 5 sessions of weekly physical therapy sessions and testing
activities
- Adequate social support to be able to participate in weekly training and assessment
sessions for the duration of 6 months within the study period.
- Ability to read and speak English
Exclusion Criteria:
- Autoimmune etiology of spinal cord dysfunction/injury
- History of additional neurologic disease, such as stroke, multiple sclerosis,
traumatic brain injury, etc.
- Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- 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.
- Active cancer
- Cardiovascular or musculoskeletal disease or injury that would prevent full
participation in physical therapy intervention
- Unhealed fracture, contracture, pressure sore, or urinary tract infection or other
illnesses that might interfere with upper extremity rehabilitation or testing
activities
- Any condition that would render the patient unable to safely cooperate with the study
tests as judged by the screening physician
- Pregnancy
- Currently on anti-spasticity medication regimen
- Botulinum toxin injections in the prior 6 months
- Dependent on ventilation support
- Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc).
- Has depression or anxiety based on Patient Health Questionnaire and General Anxiety
Disorder-7 item Questionnaire
- Alcohol and/or drug abuse.
- Cognitive impairment based on Short Portable Mental Status Questionnaire
- Unable to read and/or comprehend the consent form.
- Unable to understand the instructions given as part of the study.
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