Condition: Posttraumatic Headache · Posttraumatic Stress Disorder · Sponsor: Northwestern University
Post-Traumatic Stress Disorder (PTSD) and traumatic brain injury (TBI) with associated headache are amongst the most common injuries sustained by our deployed forces in Iraq and Afghanistan, as well as in more recent conflicts in Eastern Europe and the Middle East. This study aims to determine whether a procedural intervention (stellate ganglion block (SGB)) or medication (ketamine), alone or in combination, can alleviate PTSD and TBI-associated headache. Determining efficacious treatments in a randomized, double-blind, placebo-controlled, multicenter study trial may improve quality of life in those with TBI and PTSD, and identifying factors associated with treatment outcome (personalized medicine) may enhance selection, thereby improving the risk: benefit and cost-effectiveness ratios. Primary Objectives: 1. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache; 2. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD; 3. To determine the comparative effectiveness of SGB and ketamine infusion, and the effect of combination treatment on TBI-related headache and PTSD; 4. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance; 5. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups. Secondary Objectives:…
This description comes directly from the study's public registry record.
Jordan Wood, BS · 312-695-0915 · jordan.wood1@northwestern.edu
Always discuss trial participation with your own doctor first.
| Anesthesiology Pain Medicine Center | Chicago, Illinois, United States | Recruiting |
| Walter Reed National Military Medical Center | Bethesda, Maryland, United States | Recruiting |
| Womack Army Medical Center | Fort Bragg, North Carolina, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06608277