Status:
RECRUITING
Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinal Cord Injuries
Neuromodulation
Eligibility:
All Genders
22-60 years
Phase:
NA
Brief Summary
It has been demonstrated that the human lumbosacral spinal cord can be neuromodulated with epidural (ESS) and transcutaneous (TSS) spinal cord stimulation to enable recovery of standing and volitional...
Detailed Description
Spinal circuitries below a paralyzing injury have a functional potential that far exceeds what has been thought possible. It has been demonstrated that task-specific motor therapy combined with epidur...
Eligibility Criteria
Inclusion
- All participants must be able to provide a provision of a signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 22-60 years old Able to provide paperwork from personal primary treating physician that proves stable medical condition with ability to tolerate at least 15 minutes upright
- Able to self-transfer from the wheelchair and demonstrate active range of motion of bilateral upper extremities in gravity dependent plane
- Able to passively range bilateral lower extremities within normal mobility parameters including: greater than 90 degrees of hip flexion and 165 degrees of hip extension; greater than 90 degrees of knee flexion and reach neutral knee extension of 180 degrees; neutral ankle position reaching a minimum of 90 degrees of dorsiflexion.
- Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes.
- 1 to 6 years post spinal cord injury
- Non-progressive spinal cord injury
- Chronic motor complete SCI as defined by AIS A or B
- Neurological level of injury below T2 and above T10 (non-conus injury)
- Eligible for fMRI per safety questionnaire
- Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.
- Able to commit to the full study
Exclusion
- Currently involved in another rehabilitation training study
- Active pressure sores, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including but not limited to contractures in the upper and lower extremities)
- Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing)
- Intrathecal baclofen pump therapy for spasticity
- Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months, resulting in absence of muscle tone and precluding response to electrical stimulation therapy
- Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- Any reason the PI or treating physician may deem as harmful to the participant to enroll or continue in the study
- Body Mass Index (BMI) over 30
- Pregnancy
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06213012
Start Date
December 6 2023
End Date
August 31 2027
Last Update
January 22 2024
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030