Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-07-21
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Experimental: Non-invasive spinal cord stimulation
This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Experimental: Activity-based training
This arm will perform 30 minutes of activity-based training using leg movements.
Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Activity-based training
Motor task
Experimental: Activity-based training wtih non-invasive spinal cord stimulation
This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Activity-based training
Motor task
Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Experimental: Non-invasive spinal cord stimulation and strength training
This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Activity-based training
Motor task
Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Experimental: Non-invasive spinal cord stimulation and precision training
This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Activity-based training
Motor task
Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Experimental: Long-term activity-based training with non-invasive spinal cord stimulation
This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Activity-based training
Motor task
Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Interventions
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Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Activity-based training
Motor task
Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
16 Years
65 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Ismael Seáñez
Assistant Professor of Biomedical Engineering and Neurosurgery
Principal Investigators
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Ismael Seanez, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202206159
Identifier Type: -
Identifier Source: org_study_id
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