RecruitingNot ApplicableNCT05472584

Spinal Cord Stimulation and Training

Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury

Sponsor

Washington University School of Medicine

Enrollment

120 participants

Start Date

Jul 21, 2023

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries

Summary

This study will help the investigators better understand the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal and spinal neural circuits and how the changes impact the improvements of spinal cord stimulation (SCS) mediated motor function.

Eligibility

Min Age: 16 YearsMax Age: 65 Years

Inclusion Criteria11

Healthy Volunteers
Age between 16 and 65 years old
Healthy people with no major comorbidities of any organ system
Participants with spinal cord injury (SCI)
Age between 16-65 years old
Traumatic SCI C4-T9 level, incomplete (ASIA 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 Criteria33

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
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