Ketamine, stellate ganglion block, or both for TBI-related headache and PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial that will enroll about 175 adults and randomize them into four groups in a 2:2:2:1 ratio to receive ketamine, stellate ganglion block (SGB), the combination, or sham/placebo. The primary outcomes are patient-reported headache and PTSD measures collected at baseline and the primary endpoint at 4 weeks, with additional assessments at 1 and 2 weeks and extended follow-up for responders at 8 and 12 weeks. Several quality-of-life and symptom instruments (including HIT-6 and PCL-5) will be used to measure treatment effect, and responders who do not improve will be followed observationally for alternative care. The trial aims to identify not only whether these therapies work but which patient factors predict better outcomes to inform more personalized treatment choices.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Steven Cohen, MD — Northwestern University
• Study coordinator: Jordan Wood, BS
• Email: jordan.wood1@northwestern.edu
• Phone: 312-695-0915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.