Testing early gabapentin for recovery after spinal cord injuries
Feasibility of Early Gabapentin as an Intervention for Neurorecovery
This study is testing if giving gabapentin soon after a spinal cord injury can help people recover better compared to those who get a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05302999 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the feasibility of administering gabapentin early after spinal cord injuries to assess its potential effects on neurorecovery. Participants will be randomized into three groups, receiving either gabapentin or a placebo, starting within five days post-injury and continuing for 90 days. The study will follow participants for an additional 90 days after treatment cessation to evaluate outcomes. The research is designed to lay the groundwork for future efficacy studies by examining the initial feasibility of this intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with traumatic spinal cord injuries of any severity and level.
Not a fit: Patients with moderate to severe traumatic brain injuries or those already using gabapentinoids may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery outcomes for patients with spinal cord injuries.
How similar studies have performed: While gabapentin is commonly used for pain management in spinal cord injuries, this specific approach of early administration for neurorecovery is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Traumatic SCI; 2. All levels of SCI; 3. All severities of SCI, AIS A-D; 4. Age 18 years and older. 5. Agree to participate and start study drug within 120 hours' post-injury. 6. Adequate cognition and communication to provide informed consent Exclusion Criteria: 1. Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) \< 13 at 120 hours' post-injury. 2. Documented use of gabapentinoids at the time of injury.
Where this trial is running
Cleveland, Ohio
- MetroHealth Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Dr. Kimberly Anderson, PhD — Metrohealth Medical Center-Case Western Reserve University School of Medicine
- Study coordinator: Mayson Moore
- Email: mmoore12@metrohealth.org
- Phone: 216-957-3518
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.