Spinal Cord Injury Epidural Stimulation
- Conditions
- Spinal Cord Injury
- Interventions
- Device: Epidural Stimulator
- Registration Number
- NCT02592668
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This is a feasibility study to test the use of epidural stimulation to restore volitional function previously lost due to spinal cord injury.
Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic, have shown that direct electrical stimulation of the spinal cord increases the excitability of spared neuronal connections within the site of injury, thereby enhancing signal transmission and allowing recovery of previously lost volitional function. Recently, epidural electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord injury (SCI) has restored motor and autonomic function below the level of injury. Despite positive results, further translational research is needed to validate these findings. The goal of this proposal is to perform epidural stimulation to restore volitional function in patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
- Stable medical condition without *cardiopulmonary disease or *dysautonomia that would contraindicate standing or stepping with body weight support training
- No current anti-spasticity medication regimen
- Non-progressive spinal cord injury between the vertebral levels of C7 & T10
- American Spinal Injury Association grading scale of A or B
- Sensory evoked potentials are either not present or have a bilateral delay
- Segmental reflexes remain functional below the lesion
- At least 2-years post-injury.
- Pregnancy at time of enrollment
- Failure to obtain consent
- Prisoners
- Children (age less than 21)
- Any patient identified as unsuitable for this protocol by the Mayo study team
- Skeletal fracture
- Osteoporosis with Dual-energy X-ray absorptiometry (DEXA) t score ≤-3.5
- Uncontrolled urinary tract infections
- Presence or history of frequent decubitus ulcers
- Clinical depression
- Drug abuse
- Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training
- Current anti-spasticity medication regimen
- Voluntary motor response present in leg muscles
- Volitional control during voluntary movement attempts in leg muscles as measured by electromyography (EMG) activity
- Brain influence on spinal reflexes as measured by EMG activity
- Recordable motor evoked potential in the lower limbs with transcranial magnetic stimulation
- Implanted cardiac pacemaker
- Implanted defibrillator
- Other implanted metallic or active body worn medical electronic device such as an insulin pump
- *Cardiopulmonary disease that would result in exclusion from the study will be defined as clinically diagnosed chronic obstructive pulmonary disease, cardiac failure, and heart arrhythmia that would contraindicate sudden changes in body position such as sit-to-stand and stepping
- *Excessive and uncontrolled autonomic dysreflexia characterized by symptomatic hypotension, light headedness and hypertension, flushing and bradycardia. Additionally blood pressure monitoring will be available at all times during rehabilitation and assessment times.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active stimulation Epidural Stimulator Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function. The total estimated time for the intervention is 66 weeks.
- Primary Outcome Measures
Name Time Method Duration of time for which subject can sit unassisted on the edge of a mat table Approximately 50 weeks after implantation Assessment of volitional movement of lower limbs Approximately 50 weeks after implantation Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses Approximately 50 weeks after implantation Duration of time for which subject can stand weight bearing with minimal assistance provided as needed. Approximately 50 weeks after implantation
- Secondary Outcome Measures
Name Time Method Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing baseline, approximately 50 weeks after implantation Change in total body fat baseline, approximately 50 weeks after implantation Change in bowel function as measured by the Neurogenic Bowel Dysfunction Score questionnaire baseline, approximately 50 weeks after implantation Change in lean body mass baseline, approximately 50 weeks after implantation Change in bone density baseline, approximately 50 weeks after implantation Change in sitting balance via functional reach test baseline, approximately 50 weeks after implantation Change in volitional movement restoration via NeuroRecovery scale baseline, approximately 50 weeks after implantation Change of bladder function, as measured by the Neurogenic Bladder Symptom Score questionnaire baseline, approximately 50 weeks after implantation Change in sexual function as measured by the Sexual Function Questionnaire baseline, approximately 50 weeks after implantation Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire baseline, approximately 50 weeks after implantation Change in spasticity via Ashworth spasticity test baseline, approximately 50 weeks after implantation Change in ability of performing basic activities of daily life via spinal cord independence measure baseline, approximately 50 weeks after implantation
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States