Study Comparing Ketamine and Stellate Ganglion Block Treatments for Headaches and PTSD Related to Traumatic Brain Injury

What this Trial Is About

Researchers are studying treatments for Post-Traumatic Stress Disorder PTSD and traumatic brain injury TBI with associated headaches, which are common injuries in military personnel from various conflicts. The trial aims to evaluate whether a procedural intervention called stellate ganglion block SGB, medication ketamine, or their combination can reduce symptoms of PTSD and TBI-related headaches. This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to compare the effectiveness of these treatments and explore factors linked to treatment success. Participants will be randomly assigned to one of four groups SGB with bupivacaine plus placebo ketamine, sham SGB plus ketamine infusion, SGB plus ketamine infusion, or sham SGB plus placebo ketamine. The SGB is performed using ultrasound or fluoroscopic guidance, and ketamine or placebo is given via infusion and boluses over 30 to 60 minutes. Treatments are administered once, followed by regular assessments at 1, 2, 4, 8, and 12 weeks, with unblinding and longer follow-up at 6 and 12 months for those showing positive outcomes. During the study, participants will complete various questionnaires and assessments about headache impact, PTSD symptoms, pain levels, quality of life, anxiety, depression, and medication use. Those who respond positively continue in the trial with ongoing evaluations, while those who do not respond exit the trial but may receive other treatments as determined by their providers. Researchers will also explore brain imaging and biomarker changes in some participants to understand treatment effects better. The total participation can last up to one year for some individuals based on their response.

Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD