💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 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 Criteria:
* 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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