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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorThe Methodist Hospital Research Institute

About this trial

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 criteria

Qualifiers

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 22-75 years old.

Documentation from the participant's primary treating physician confirming a stable medical condition.

Disqualifiers

Ability to maintain standing independently without external support.

Currently involved in another rehabilitation training of the lower extremities.

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).

Trial design

Treatments tested in this trial

  • Transcutaneous Spinal cord Stimulation
  • Epidural Spinal Stimulation (ESS)

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

The Methodist Hospital Research Institute

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator