Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT06520020
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06520020
Study Brief:
Protocol Section:
NCT06520020