NCT06608277 Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD
| NCT ID | NCT06608277 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Northwestern University |
| Condition | Posttraumatic Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 175 participants in total. It began in 2025-07-02 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Steven Cohen, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT06608277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Posttraumatic Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06608277 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06608277 currently recruiting?
Yes, NCT06608277 is actively recruiting participants. Contact the research team at jordan.wood1@northwestern.edu for enrollment information.
Where is the NCT06608277 trial being conducted?
This trial is being conducted at Chicago, United States, Bethesda, United States, Fort Bragg, United States.
Who is sponsoring the NCT06608277 clinical trial?
NCT06608277 is sponsored by Northwestern University. The principal investigator is Steven Cohen, MD at Northwestern University. The trial plans to enroll 175 participants.