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RecruitingPhase 2

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

NCT06608277 · Northwestern University

Recruiting
Status
Accepting participants
Phase 2
Phase
175
Target enrolment
3
Study sites
3 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Headache Impact Test (HIT-6)

    Measured over 4 weeks

  • PTSD Checklist (PCL-5)

    Measured over 4 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Adults 18 years or older 2. Stable doses of medications for \> 2 weeks for TBI and/or PTSD 3. 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. 4. Duration of chronic TBI or PTSD \> 3 months Exclusion Criteria: 1. Ketamine infusion or SGB within the past 6 months 2. Serious medical or psychiatric conditions other than TBI or PTSD that could affect cognition (e.g., dementia, Parkinson's Disease) 3. Elevated intracranial pressure 4. For TBI, prior history of headache that can explain the headache intensity (i.e., headache not attributable to TBI) 5. Active psychosis or poorly controlled non-injury or PTSD-related psychiatric condition (e.g., bipolar disorder) 6. Poorly controlled medical conditions that could be exacerbated by treatment (e.g., unstable angina) 7. Pregnancy (women of childbearing age who can become pregnant will have to take a pregnancy test) 8. Non-fluency in English (poor generalizability to military and veteran populations, instruments not validated for use or translated in many languages)

Where

3 study sites

FacilityCityRegionCountry
Anesthesiology Pain Medicine CenterChicagoIllinoisUnited States
Walter Reed National Military Medical CenterBethesdaMarylandUnited States
Womack Army Medical CenterFort BraggNorth CarolinaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06608277 on ClinicalTrials.gov →

Last updated in the registry 2026-05-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 3 trials from Northwestern University →