This randomised, double-blind, placebo-controlled trial (n=175) will investigate the efficacy of stellate ganglion block (SGB) and ketamine infusion, both separately and in combination, in treating post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI)-associated headaches.
The study, sponsored by Northwestern University, aims to determine whether these interventions can provide relief for military personnel and veterans who have sustained injuries in conflicts.
Participants will be randomly assigned to one of four groups, receiving either SGB with bupivacaine, ketamine infusion, a combination of both, or placebo treatments. The primary outcomes will be assessed using the Headache Impact Test (HIT-6) and PTSD Checklist (PCL-5) at four weeks, with further follow-ups at eight and twelve weeks for responders. Additional exploratory measures, including neuroimaging and biomarker analysis, will be conducted to identify factors associated with treatment success. The study is expected to run from February 2025 to April 2028, with sites in the United States and Ukraine.
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Northwestern UniversityThis company doesn't have a full profile yet, it is linked to a clinical trial.