Feasibility of gabapentin as an intervention for neurorecovery after an acute spinal cord injury: Protocol

Frontiers in Neurology, 2022 · DOI: 10.3389/fneur.2022.1033386 · Published: November 7, 2022

Spinal Cord Injury Pharmacology Neurorehabilitation

Simple Explanation

This study is a protocol for a trial to determine if gabapentin can be used to help with recovery after a spinal cord injury. Gabapentin is typically used for seizures and nerve pain. The trial aims to determine if it is feasible to administer gabapentin early after a spinal cord injury, restrict its dosage, and not use it for pain management. The study will involve 42 participants who will be given either a low dose of gabapentin, a medium dose, or a placebo within 120 hours of their injury, and they will be monitored for 90 days.

Study Duration

6 Months

Participants

42 people with traumatic spinal cord injury

Evidence Level

Not specified

Key Findings

1
The study aims to assess the feasibility of recruiting the target population, delivering the drug treatment protocol, maintaining blinding, and retaining participants.
2
The trial will inform research and clinical practice on the effects of manipulating gabapentin for non-pain management purposes in the acute setting.
3
Outputs from this trial will guide the development of a properly powered efficacy trial of gabapentin as an intervention for neurorecovery in spinal cord injury.

Research Summary

This protocol describes a prospective, mock-efficacy, dose exploration trial to test the feasibility of administering gabapentin in the acute setting as an intervention for neurorecovery after spinal cord injury. The trial will enroll 42 participants with traumatic SCI, randomized to receive either 600 mg/day gabapentin, 1,800 mg/day gabapentin, or placebo, with the first dose administered within 120 hours post-injury and continued for 90 days. The key analysis parameters will evaluate feasibility of recruitment of target population, delivery of drug treatment protocol, maintenance of blinding, and retention of participants.

Practical Implications

Research Advancement

The trial's findings will inform future research directions and the design of properly powered efficacy trials to investigate gabapentin's neurorecovery potential after SCI.

Clinical Practice

The study will provide insights into the effects of manipulating gabapentin for non-pain management purposes in the acute SCI setting, potentially leading to new clinical strategies.

Drug Repurposing

The research supports the repurposing of gabapentin, an FDA-approved and widely used medication, for neurorecovery in SCI, potentially offering a cost-effective and accessible intervention.

Study Limitations

1
The placebo and gabapentin capsules are not identical, potentially leading to unblinding and bias.
2
Broad inclusion criteria and the randomization scheme may impact the interpretability of efficacy results due to heterogeneity of neurorecovery across injury levels and AIS grades.
3
Protocol modification may be necessary to address heterogeneity of neurorecovery in a properly powered efficacy trial, even if feasibility benchmarks are met.

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