Feasibility of Early Gabapentin as an Intervention for Neurorecovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gabapentin, Placebo.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Gabapentin is a medication commonly used in spinal cord injury (SCI) to manage neuropathic pain. Emerging preclinical and clinical evidence suggests that early initiation of low to medium doses of gabapentin and continued delivery for a range of 2 weeks to 4 months has a persistent, positive effect on motor and autonomic neurologic recovery. The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the early administration of gabapentin as an intervention for neurorecovery. A mock efficacy design will be employed. Participants will be stratified based on ASIA Impairment Scale (AIS) grade A-B or C-D and randomized to 1 of 3 arms. Study medication will be initiated within 5 days post-injury and administered for 90 days. Participants will be followed for an additional 90 days after stopping treatment.
Interventions
- Drug Gabapentin
Generic gabapentin - Drug Placebo
Inert cellulose
Primary outcome measures
- Number of participants recruited [Time frame: During the first 120 hours post-injury]
- Adherence rate to drug treatment protocol [Time frame: Across 90 day treatment window]
- Number of occurrences of unblinding [Time frame: Across 6 month study duration per participant]
- Retention rate [Time frame: Across 6 month study duration per participant]
Eligibility criteria
Inclusion criteria
- Traumatic SCI;
- All levels of SCI;
- All severities of SCI, AIS A-D;
- Age 18 years and older.
- Agree to participate and start study drug within 120 hours' post-injury.
- Adequate cognition and communication to provide informed consent
Exclusion criteria
- Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) < 13 at 120 hours' post-injury.
- Documented use of gabapentinoids at the time of injury.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- MetroHealth Medical Center — Cleveland
Publications
- Wilson JR, Doty S, Petitt JC, El-Abtah M, Francis JJ, Sharpe MG, Kelly ML, Anderson KD. Feasibility of gabapentin as an intervention for neurorecovery after an acute spinal cord injury: Protocol. Front Neurol. 2022 Nov 7;13:1033386. doi: 10.3389/fneur.2022.1033386. eCollection 2022. PMID 36419530
Identifiers
NCT: NCT05302999 · IRB21-00609