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Project

Transcutaneous spinal stimulation to improve hand function after SCI

Funder: Craig H Neilsen Foundation

Funding period
USD 300 K
Funding amount
Abstract
Restoration of hand and arm function is the highest treatment priority for consumers with tetraplegia due to spinal cord injury (SCI). Epidural stimulation of the spinal cord is showing impressive results in returning function to individuals with even motor complete injuries. New technology is permitting similar and perhaps even more rapid improvements by allowing stimulation of the skin surface to activate the spinal cord transcutaneously. A 10 kHz carrier frequency effectively anesthetizes the skin and permits over 70 mA of current to be delivered through the skin without causing discomfort. We have begun to leverage this new technology, applying skin surface stimulation over the cervical spinal cord. We have observed unprecedented improvements in hand, arm and bladder function in our first participant with a C3 spinal cord injury. Here we propose to conduct a rigorous study of transcutaneous cervical spinal stimulation in 10 participants to determine both the immediate and long-term benefits to hand function and quality of life.Transcutaneous cervical stimulation will be delivered for 2 hour/day while subjects participate in intensive physical and occupational therapy 2-3 days/week for 4 weeks. Subjects more than 1 year post injury will be randomized to first receive either stimulation + therapy, or therapy alone. After 1 month, they will cross-over to the other arm so as to serve as their own controls in this heterogeneous population. Physical and occupational therapy will be equivalent each month such that the additional benefits conferred by stimulation are quantified.Validated functional tests (e.g., GRASSP), quality of life surveys (e.g., WHO-QOL), and ISNCSCI exams will be performed multiple times at baseline, every two weeks during the intervention and cross-over periods, and monthly for 3 months following to detect sustained improvements in function. Based on promising preliminary data, we expect substantial and sustained improvements in motor, sensory and bladder function. To uncover the mechanisms of action, standardized electrophysiological test are repeated throughout the study (e.g., SSEPs and H-reflex test). IRB approval is in place for the 10 participants, and an independent data and safety monitoring board has been formed. Risk will be mitigated by the non-invasive nature of the stimulation, and by excluding participants with a history of autonomic dysreflexia or other serious health problems from these initial studies. We have assembled a strong team of clinicians (MD physiatrists, neurosurgeon, physical and occupational therapists) and electrophysiology researchers to quantify this promising approach for improving hand function for people with chronic cervical SCI. (CHN: SCIRTS chn:wdg)
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System

Categories
  • FOR (ANZSRC)

    1103 Clinical Sciences

  • RCDC

    Injury (total) Accidents/Adverse Effects

  • RCDC

    Injury - Trauma - (Head and Spine)

  • RCDC

    Neurosciences

  • RCDC

    Rehabilitation

  • RCDC

    Spinal Cord Injury

  • RCDC

    Clinical Research

  • RCDC

    Clinical Trials and Supportive Activities

  • RCDC

    Neurodegenerative

  • RCDC

    Physical Rehabilitation

  • HRCS HC

    Neurological

  • HRCS HC

    Injuries and Accidents

  • Health Research Areas

    Clinical

  • Broad Research Areas

    Clinical Medicine and Science