Spinal Cord Injuries Clinical Trial
Official title:
Feasibility of Early Gabapentin as an Intervention for Neurorecovery
The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | MetroHealth Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
MetroHealth Medical Center | National Institute on Disability, Independent Living, and Rehabilitation Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants recruited | Feasibility question - Can the target population be recruited?
Feasibility measure - Number screened/month; number enrolled/month; reasons for not enrolling Quantitative benchmark of success - Screen an average of 4/month; Enroll an average of 1/month |
During the first 120 hours post-injury | |
Primary | Adherence rate to drug treatment protocol | Feasibility question - Can the drug treatment protocol be delivered?
Feasibility measure - Proportion of enrolled who receive the full drug treatment protocol (placebo arm; two gabapentin dose arms); number of dosing deviations/arm; reasons for dosing deviations Quantitative benchmark of success - 70% enrolled in placebo arm receive full dosing protocol; 70% enrolled in each gabapentin arm receive full dosing protocol |
Across 90 day treatment window | |
Primary | Number of occurrences of unblinding | Feasibility question - Can the assessors remain blinded?
Feasibility measure - Number of occurrences of unblinding; reasons for unblinding Quantitative benchmark of success - 5% or fewer occurrences of unblinding |
Across 6 month study duration per participant | |
Primary | Retention rate | Feasibility question - Will participants complete the study?
Feasibility measure - Retention rate; reasons for dropout; proportion of planned assessments completed Quantitative benchmark of success - 70% of participants stay enrolled until the end of the study and complete 3 of the 4 assessment visits |
Across 6 month study duration per participant |
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