Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
Francis Farhadi
30 participants
Oct 23, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 undergo, or have had, surgical intervention. -. The ability to undergo transcutaneous intervention including study procedures in the posterior cervical or thoracic midline at or after 14 days from surgery.
Exclusion Criteria13
- 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.
- Unable to commit to the follow-up schedule.
- Recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study.
- Any condition likely to result in the patient's death within the next 12 months.
- Prisoner.
- Pregnancy.
- Cardiac pacemaker dependent, unable to undergo electrical stimulation.
- Brain implant, skull prosthesis, plate and screws limiting transcranial stimulation.
- Tattoo at site of skin electrode that causes heat/pain during stimulation.
- Subjects who in the opinion of the investigator are not suitable for inclusion in the study, with reason documented.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06520020