Spinal Cord Injuries Clinical Trial
Official title:
Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury
NCT number | NCT05472584 |
Other study ID # | 202206159 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 21, 2023 |
Est. completion date | August 2027 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | August 2027 |
Est. primary completion date | August 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Motor evoked potentials amplitude and latency | This primary outcome is a measure of changes in corticospinal tract excitability and plasticity as quantified by changes in the amplitude size and onset latency of motor evoked potentials elicited via transcranial magnetic stimulation. | 30 minutes before and 30 minutes after intervention; 4 weeks | |
Primary | Reaction time to startle response | This primary outcome is a measure of changes in reticulospinal tract excitability after training as quantified by changes in reaction time after a startling auditory stimulus. | 30 minutes before and 30 minutes after intervention; 4 weeks | |
Primary | F-wave response persistence | This primary outcome is a measure of changes in spinal motoneuron excitability as quantified by changes in the persistence of F-wave responses elicited via peripheral nerve stimulation. | 30 minutes before and 30 minutes after intervention; 4 weeks | |
Secondary | Changes in time to completion from baseline | Participants will perform cursor control as a computer game. This outcome measure is the time it takes participants to complete each task. | Baseline, 30 minutes, and 4 weeks | |
Secondary | Change in movement smoothness | This outcome is a measure of changes in movement smoothness when operating the computer cursor with the body. | Baseline, 30 minutes, and 4 weeks |
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