Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study

Launched by FRANCIS FARHADI · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called transcutaneous spinal cord stimulation, which uses electrical stimulation to help patients with spinal cord injuries. The study aims to understand how safe and practical this treatment is for different groups of patients: those with non-traumatic spinal cord injuries, patients who have recently experienced a traumatic spinal cord injury, and those who suffered a traumatic injury 6 to 24 months prior. A total of 30 participants will be included in the study, and the researchers hope to learn more about how this treatment could help improve their condition.

To be eligible for the trial, participants must be between 18 and 80 years old and have a specific type of spinal cord injury that affects their ability to move. They should not have other serious health conditions or infections and must be able to provide consent for participation. Those who join the study can expect to undergo the spinal stimulation treatment and participate in follow-up assessments to monitor their progress. It's important to know that this study is currently recruiting participants, and if someone is interested, they should discuss it with their healthcare provider to see if they meet the eligibility criteria.

Gender

ALL

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.