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โ† Trials
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Spinal Cord Stimulation and Training

RecruitingNAAges 16 Years - 65 YearsAllWashington University School of Medicine
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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, 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 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
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What it tests

  • Electrophysiology assessment - corticospinal tract
  • Electrophysiology assessment - reticulospinal tract
  • Electrophysiology assessment - spinal motoneuron
  • Activity-based training
  • Transcutaneous spinal cord stimulation
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Where

1 site
Washington University
St Louis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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