Surgical treatment for spinal cord injuries using nerve grafts
Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty
NA · University of Kentucky · NCT06243211
This study is testing a new surgical method using nerve grafts to see if it can help people with recent spinal cord injuries recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06243211 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety, feasibility, and preliminary efficacy of a surgical approach combining dorsal myelotomy and expansive duraplasty with or without autologous nerve graft implantation in patients with acute traumatic spinal cord injuries. The study involves ten participants who will be randomly assigned to one of two treatment groups, with both participants and assessors blinded to the allocation. The goal is to assess the potential benefits of reducing intraspinal pressure and improving clinical outcomes following spinal cord injury. Additionally, nerve samples will be collected for further analysis to understand the underlying mechanisms of recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with acute cervical or thoracic spinal cord injuries classified as ASIA Impairment Scale grade A or B.
Not a fit: Patients with spinal cord injuries classified as ASIA Impairment Scale grade C, D, or E, or those who can be treated safely through an anterior-only approach may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and quality of life for patients with spinal cord injuries.
How similar studies have performed: While few studies have explored similar surgical techniques, the approach of reducing intraspinal pressure through myelotomy has not been widely tested in clinical settings, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: = 18 years and = 80 years * Written informed consent by patient or legal authorized representative * No other life-threatening injury * No evidence of sepsis * Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission * Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12 * The ability to undergo surgical intervention including study procedures through a posterior approach within 48 hours of injury Exclusion Criteria: * Unconsciousness or other mental impairment that prevents neurological assessment within the first 48 hours * Acute SCI with ASIA Impairment Scale grade C, D or E * Spinal cord decompression and spinal stabilization can be safely performed through an anterior-only approach (i.e. posterior approach is not required) * Currently involved in another non-observational SCI research study or receiving another investigational drug * Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the principal investigator) * Unable to commit to the follow-up schedule * A 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 * Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented). * Pregnancy
Where this trial is running
Lexington, Kentucky
- University of Kentucky - Chandler Medical Center — Lexington, Kentucky, United States (RECRUITING)
Study contacts
- Principal investigator: Francis H Farhadi, MD, PhD — University of Kentucky Neurosurgery
- Study coordinator: Francis H Farhadi, MD, PhD
- Email: francis.farhadi@uky.edu
- Phone: 859-323-5661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Acute Traumatic Spinal Cord Injury, Decompression, Dorsal, Duraplasty, Myelotomy, Nerve Graft