Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 control of the lower limbs after complete motor paralysis due to spinal cord injury (SCI). The work proposed herein will examine and identify distinct electrophysiological mechanisms underlying transcutaneous spinal stimulation (TSS) and epidural spinal stimulation (ESS) to define how these approaches determine the ability to maintain self-assisted standing after SCI.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 60
Healthy Volunteers: t
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• 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

Locations
United States
Texas
Houston Methodist Hospital
RECRUITING
Houston
Contact Information
Primary
Rachel Markley, MPH
rmarkley@houstonmethodist.org
(713)-441-3770
Backup
Jenny Dinh
jtdinh@houstonmethodist.org
(346)-238-4654
Time Frame
Start Date: 2023-12-06
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Transcutaneous Spinal Stimulation (TSS)
Spinal Stimulation delivered over the skin using a research stimulator with conventional surface electrodes during research visits.
Sham_comparator: Sham
Sham Stimulation delivered over the skin using a research stimulator with conventional surface electrodes during research visits. Sham stimulation will be delivered using the intensity of stimulation set as during active sessions of ESS, but then gradually decreased down to zero in approximately 30 s. There will be 5-10 minute breaks interspersed between intervals of stimulation, and will vary according to the individual's tolerance and fatigue levels
Experimental: Epidural Spinal Stimulation (ESS)
Stimulation delivered internally using an implanted device operated by an external control (only used during research visits).
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov

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