Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
NCT Number: NCT06520020
Acronym: STIM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Stimulation|Electric Stimulation Therapy|Traumatic Spinal Cord Injury|Cervical Myelopathy
Interventions: DEVICE: Transcutaneous Spinal Cord Stimulation (Tc-SCS)
Sponsor: H. Francis Farhadi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-06-30
Locations: University of Kentucky - Chandler Medical Center, Lexington, Kentucky, 40536-0298, United States

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.

Primary Outcome Measures: 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., Twelve Months|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)., Twelve Months|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)., Perioperative|Blood Pressure, Systolic and diastolic. Measured in mmHg, Perioperative|Orthostatic Blood Pressure, As defined by a sustained reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg within three minutes of standing after being supine for five minutes., Perioperative|Post-Void Residual, Defined as the amount of urine remaining in the bladder following urination. Measured in milliliters., Perioperative|Upper Extremity: Grip Strength, Dynamometry measuring grip strength of both hands with participant directed to squeeze a force gauge between their thumb base and fingers at the distal interphalangeal joint. Average of three attempts, measured in kg of force., Twelve Months|GRASSP, Gross and fine motor function of the hand is tested with subcomponents while manipulating common, but standardized, objects including jar and water bottle opening, grasping of key, coin, nut and bolt, and nine-peg test. Measured in time (seconds) to completion and/or percentage of completion in a given time period., Twelve Months|Lower Extremity: 10 Meter Walk Test, The participant is instructed to walk as fast and accurately as possible across a 10- meter length of hallway, without adaptive devices. This can be consistently recorded whether starting at rest or when already walking 'at speed'. Measured in seconds., Twelve Months|GAITRite Walking Assessment, Quantitative analysis of gait using an electronic pressure mat, measured with gait stability ratio (single stance time / double stance time). Measured in time (seconds) and distance (centimeters)., Twelve Months|SCIM-vIII (PROM), self-reported questionnaire comprised of 19 questions on daily tasks with a total score between 0 and 100 and subscales for self-care, respiration \& sphincter management, and mobility., Twelve Months|WHOQOL-BREF, A questionnaire validated in, but not specific to, people with SCI. The WHOQOL-BREF been found to have excellent reliability, adequate-to-excellent validity with complete and incomplete SCI, and acceptable ceiling or floor effects. Measured as a raw score and converted to a percentage with higher values indicating a more positive result., Twelve Months
Secondary Outcome Measures: 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., Twelve Months|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., Twelve Months|Adherence to Protocol, Documentation of completion of protocol waypoints (i.e. follow-up visits, intervention steps) expressed as a rate., Twelve Months|Data Collection and Monitoring, Documentation of completed data collection waypoints expressed as a rate., Twelve Months