Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
Francis Farhadi
Summary
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.
Description
Spinal cord injury (SCI) can result from primary physical insults such as acute trauma, or secondary insults that result from chronic compression and ischemia. The resultant neurological impairment leads to high personal and societal burden. There are few effective therapies to improve function for those living with SCI. Spinal cord stimulation (SCS) represents a safe and potentially effective treatment for persons with SCI-related pain and paralysis. The aim of this study is to investigate the potential clinical utility of SCS delivered transcutaneously in patients at various stages of SCI, r…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * No evidence of superficial skin infection at site of surgery and intervention. * An established diagnosis of either: * cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or * acute cervical / thoracic SCI with ASIA Impairment Scale grade A-D (as assessed within 72 hours of injury) with neurologic level of injury (NLI) from C2 to T12. * The ability to underg…
Interventions
- DeviceTranscutaneous Spinal Cord Stimulation (Tc-SCS)
This 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.
Location
- University of Kentucky - Chandler Medical CenterLexington, Kentucky