Actively Recruiting
Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD
Led by Northwestern University · Updated on 2026-05-01
175
Participants Needed
3
Research Sites
147 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
W
Walter Reed National Military Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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: 1. 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 (Biomedical levels and MRI not included at Northwestern University Site). 2. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.
CONDITIONS
Official Title
Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Stable doses of medications for more than 2 weeks for TBI and/or PTSD
- For TBI-associated headache with or without PTSD: HIT-6 score of 53 or higher
- For PTSD with or without TBI-associated headache: PCL-5 score of 33 or higher
- For those with both TBI and PTSD and lower scores: HIT-6 score of 50-52 and PCL-5 score of 31 or 32
- Duration of chronic TBI or PTSD greater than 3 months
You will not qualify if you...
- Ketamine infusion or stellate ganglion block within the past 6 months
- Serious medical or psychiatric conditions other than TBI or PTSD that could affect cognition (e.g., dementia, Parkinson's Disease)
- Elevated intracranial pressure
- Prior history of headache explaining headache intensity not attributable to TBI
- Active psychosis or poorly controlled psychiatric conditions unrelated to injury or PTSD (e.g., bipolar disorder)
- Poorly controlled medical conditions that could be worsened by treatment (e.g., unstable angina)
- Pregnancy (women who can become pregnant must take a pregnancy test)
- Non-fluency in English
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Anesthesiology Pain Medicine Center
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Actively Recruiting
3
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
Not Yet Recruiting
Research Team
J
Jordan Wood, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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