Feasibility of Early Gabapentin as an Intervention for Neurorecovery
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetroHealth Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Traumatic SCI;
All levels of SCI;
All severities of SCI, AIS A-D;
Age 18 years and older.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gabapentin
- Placebo
Treatment groups
42 Participants
are divided into 3 treatment groupsSponsors and collaborators
MetroHealth Medical Center
Lead sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
Source ClinicalTrials.gov