Possibilities
Clinical Trials:
The E-Stand trial is done at the “Minneapolis VA Health Care System”
E-Stand stands for Epidural Stimulation After Neurologic Damage and the E-Stand trial has verified that epidural spinal cord stimulation can restore some volitional movement and improve cardiovascular, bowel, and bladder function. Currently, E-STAND is the second largest study in the world to study the use of epidural spinal cord stimulation to restore function after thoracic spinal cord injury. . A majority of our data collection is done remotely through a tablet application. Participants come on site and do follow-ups every month where the engineers and medical doctors use the data to optimize the therapy. So the patient gets individualized treatment, focusing on the quality of life improvements that the patient is most interested in.
Examples of quality of life improvements include:
- Reduced spasticity in muscles
- Voluntary movement
- Core support
- Bowel and urinary control
- Cardiovascular improvement
Clinical Process:
- Initial: Collaboration between SCID Physician, Neurosurgeon and physical therapist to discuss benefits, risk, expectations prior to stimulator placement
- Day of surgery: Collaboration with Abbott Clinical Specialist and EMG technician for initial (producer electrical stimulation device) mapping in the operation room: ensure optimal placement of epidural spinal stimulator with fluoroscopy
- Post Op: Inpatient or outpatient physical therapy for ongoing optimization and programming of the epidural spinal cord stimulator based on individual response using palpation, visual observation and feedback from the patient
- Follow-Up: Tele-health virtual clinic visits, ongoing outpatient therapy at the Minneapolis VA or at their spoke site [2]
The E-STAND trial was made to formally test the use of epidural spinal cord stimulation for restoring volitional movement in the legs of patients who suffered spinal cord injury and have been unable to move since injury. In addition, the trial was constructed to figure out how to choose stimulation settings that provide the largest improvement in movement.
The E-STAND trial is also hoping to begin to understand how epidural spinal cord stimulation in this patient population can affect blood pressure, heart function, urinary function, bowel function and some aspects of cognitive function.
Here you can see the list of Inclusion/Exclusion criterias:
Inclusion Criteria:
- 22 years of age or older
- Able to undergo the informed consent/assent process
- Stable, motor-complete paraplegia
- -Discrete spinal cord injury between C6 and T10
- ASIA A or B Spinal Cord Injury Classification
- Medically stable in the judgment of the principal investigator
- Intact segmental reflexes below the lesion of injury
- Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
- Willing to attend all scheduled appointments
Exclusion Criteria:
- Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
- Inability to withhold antiplatelet/anticoagulation agents perioperatively
- Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia.. A single tilt table test with syncope, presyncope, or SBP < 50 or >200.
- Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
- Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
- Clinically significant mental illness in the judgment of the principal investigator
- Botulinum toxin injections in the previous 6 months
- Volitional movements present during EMG testing in bilateral lower extremities
- Unhealed spinal fracture
- Presence of significant contracture
- Presence of pressure ulcers
- Recurrent urinary tract infection refractory to antibiotics
- Current Pregnancy [1]
Getting a epidural stimulator implanted besides clinical trials:
One of the few possibilities so far we know of getting an epidural stimulator implanted besides a clinical trial - it is done in the same way but next to the E-Stand clinical trial. So even when you for any reason do not fit in the Inclusion/Exclusion criterias you can still get an epidural stimulator implanted. It’s covered so far in any case done for US Citizens, not for non US US Citizens. If you come from abroad you need to pay for the moment.
Useful links
