Status:
TERMINATED
Neural Facilitation of Movements in People With SCI
Lead Sponsor:
Washington University School of Medicine
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief Summary
Spinal cord injury leads to long-lasting paralysis and impairment. Re-enabling movement of paralyzed areas is challenging and more information is needed about neurological recovery. The purpose of thi...
Detailed Description
Spinal cord injury leads to long-lasting motor impairment and paralysis that currently is not "curable". Electrical spinal cord stimulation (SCS) is beginning to be used as a neuromodulation technique...
Eligibility Criteria
Inclusion
- Healthy volunteers
- Age between 16-65
- Healthy individuals with no major conditions of any organ system
Exclusion
- Healthy volunteers
- 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
- History of epilepsy
- Implanted metal
- Active medical problems
- Inclusion criteria:
- Participants with spinal cord injury (SCI)
- Age between 16-65
- 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)
- 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 such as 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 visuo-spatial 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
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05354206
Start Date
June 23 2022
End Date
March 6 2023
Last Update
November 22 2024
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63105