RecruitingPhase 2

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

United States175 participantsStarted 2025-07-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults 18 years or older
. Stable doses of medications for \> 2 weeks for TBI and/or PTSD
. For TBI-associated headache with or without PTSD: HIT-6 score of \>/=53. For PTSD with or without TBI-associated headache: PCL-5 score \>/=33 OR. For those with TBI and PTSD, and a HIT-6 score \< 53 and PCL-5 score of \<33, individuals with a HIT-6 score of 50-52 and a PCL-5 score of 31 or 32 will be included.
. Duration of chronic TBI or PTSD \> 3 months

Exclusion criteria

. Ketamine infusion or SGB 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing ketamine, stellate ganglion block (SGB), and a combination of both — can you help me understand how each of these treatments is thought to work for TBI-related headache or PTSD, and why comparing them matters?
2Since this is a Phase 2 trial, what does that mean for how much is already known about the safety and effectiveness of ketamine and SGB together, especially for someone with my specific history of TBI?
3The trial is measuring outcomes using the HIT-6 headache scale and the PCL-5 PTSD checklist — what would a meaningful improvement on those scores actually look like in terms of how I might feel day to day?
4Are there standard treatments for post-traumatic headache or PTSD that I should consider trying first before enrolling in a study that's still testing which approach works best?
5What would the treatment schedule actually involve — how many visits, how are the ketamine infusions or nerve block injections administered, and is that realistic given my work, family, or travel situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Headache Impact Test (HIT-6)

Timeframe: 4 weeks

PTSD Checklist (PCL-5)

Timeframe: 4 weeks

Trial details

NCT IDNCT06608277

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Jordan Wood, BS

312-695-0915 jordan.wood1@northwestern.edu

View on ClinicalTrials.gov More Posttraumatic Headache trials