Spinal Cord Stimulation and Training
Spinal Cord Injuries
About this trial
This is an interventional basic science trial for Spinal Cord Injuries focused on measuring spinal cord injury, spinal cord stimulation, rehabilitation
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers
- Age between 16 and 65 years old
- Healthy people with no major comorbidities of any organ system
Exclusion Criteria:
Healthy Volunteers
- Subjects younger than 16 or older than 65 years old
- Subjects not providing consent or not able to consent
- Subjects with any acute or chronic pain condition
- Subjects with any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study period
- Use of caffeine with 3 hours of study appointment
Inclusion criteria:
Participants with spinal cord injury (SCI)
- Age between 16-65 years old
- Traumatic SCI C4-T9 level, complete (ASIA A) or incomplete (ASIA B, C or D)
- at least 1 year post injury
- Stable medical condition
- difficulty independently performing leg movements in routine activities
- able to follow simple commands
- able to speak and respond to questions
Exclusion criteria:
Participants with spinal cord injury (SCI)
- Subjects younger than 16 or older than 65 years old
- Not willing or able to provide consent
- Any acute or chronic pain condition
- Any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study appointment
- Use of caffeine with 3 hours of study appointment
- Presence of tremors, spasms and other significant involuntary movements
- Etiology of SCI other than trauma
- Concomitant neurologic disease traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy)
- History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc).
- Severe joint contractures disabling or restricting lower limb movements.
- Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities
- Depression, anxiety, or cognitive impairment
- Deficit of visuospatial orientation
- Sitting tolerance less than 1 hour
- Severe hearing or visual deficiency
- Miss more than 3 appointments without notification
- Unable to comply with any of the procedures in the protocol
- Botulinum toxin injection in lower extremity muscles in the prior six months
- Any passive implants (osteosynthesis material, metallic plates or screws) below T9.
- Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.)
- History of alcoholism or another drug abuse
- Pregnancy (or possible pregnancy)
- Having an Intrathecal Baclofen Therapy Pump (ITB pump)
- History of epilepsy
Sites / Locations
- Washington UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental: Non-invasive spinal cord stimulation
Experimental: Activity-based training
Experimental: Activity-based training wtih non-invasive spinal cord stimulation
Experimental: Non-invasive spinal cord stimulation and strength training
Experimental: Non-invasive spinal cord stimulation and precision training
Experimental: Long-term activity-based training with non-invasive spinal cord stimulation
This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
This arm will perform 30 minutes of activity-based training using leg movements.
This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation