The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups:
1. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention. 2. Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 3. Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury.
Age: = 18 years and = 80 years.
Written informed consent by patient and/or legal authorized representative (LAR).
No other life-threatening condition.
No evidence of sepsis.
Any concomitant impairment of the upper and lower limb at baseline that could potentially confound the neurologic assessments; including but not limited to traumatic or disease conditions like brachial plexus injury, peripheral neuropathy, spinal hematoma, transverse myelitis, non-compressive myelopathy, dementia, and Parkinson's disease.
mJOA of >= 15 and <= 7, or AIS grade E tSCI at baseline assessment.
Currently involved in another non-observational ntSCI or tSCI study, or receiving another interventional drug, that could interfere with recordings and confound adverse events.
Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation, at discretion of the treating surgeon and/or principal investigator.
Parallel
Transcutaneous Spinal Cord Stimulation (Tc-SCS)
DeviceThis study will employ a DS8R Biphasic Constant Current Stimulator (Digitimer, Hertfordshire, United Kingdom) to administer transcutaneous (Tc) SCS through bursts of biphasic rectangular pulses, each lasting 400 μs to 1 ms, at 30 Hz frequency on a carrier frequency is 10 kHz. The intensity of stimulation will be 120% the threshold intensity that elicits visible twitch or motor evoked potential (MEP) triggered in the biceps brachii (BB) or abductor pollicis brevis (APB) muscle for upper extremity, and quadriceps femoris (QF) or tibialis anterior (TA) in the lower extremity.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
An empirically validated and open worksheet for evaluation of sensation from C2 to S4-5, and motor strength of all major limb myotomes from C5-T1 and L2-S1. This determines the neurologic level of injury (NLI) and severity of motor and sensory completeness, with sensorimotor complete, sensory incomplete, motor incomplete without anti-gravity strength, motor incomplete with anti-gravity strength, and no significant deficit.
ASIA Impairment Scale (ASIA / AIS)
The product of the ISNCSCI examination includes a standard motor score (0-5) in five muscle groups in upper and lower extremity bilaterally with total extremity motor score of 100 (5 x \[5 upper + 5 lower\] x 2).
Modified Japanese Orthopaedic Association (mJOA)
Validated in cervical myelopathy, the mJOA scale is a patient reported functional scale with 18 points assessing four domains, including: upper extremity (0 - 7), lower extremity (0-7), sensory (0-3), and micturition (0-3). This scale is further divided into severe (\</=11), moderate (12-14), and mild (\>/=15), with scores \<8 reflecting inability to perform clinical assessments (and are excluded).
Blood Pressure
Systolic and diastolic. Measured in mmHg
Adverse Event Rate
An adverse event is any undesirable experience associated with the use of a medical product or intervention in a patient. Will be documented as a log and quantified against the number of enrolled participants as a percentage.
Serious Adverse Event Rate
A serious adverse event is an adverse event that results in: * Death * The participant experiencing a substantial risk of dying at the time of the event. * Admission to the hospital, or prolongation of hospitalization. * Disability, or permanent physical function. * Other serious o important medical events as determined by the principal investigator. Will be documented as a log and quantified against the number of enrolled participants as a percentage.
Adherence to Protocol
Documentation of completion of protocol waypoints (i.e. follow-up visits, intervention steps) expressed as a rate.
Data Collection and Monitoring
Documentation of completed data collection waypoints expressed as a rate.
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Francis Farhadi
Lead sponsor
University of Kentucky
Sponsor institution
