Could a nerve block or ketamine ease PTSD and headaches after brain injury?
NCT ID NCT06608277
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a nerve block (stellate ganglion block) or the drug ketamine, alone or together, can reduce headaches and PTSD symptoms in people who have had a traumatic brain injury. About 175 adults will receive one of four treatments, including sham procedures, to see which works best. The goal is to find a safe, effective way to improve quality of life for those with these common post-injury conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketamine
- What this could lead to
- If successful, this could provide a new, effective treatment option for people suffering from both TBI-related headaches and PTSD.
- What could go wrong
- This is a mid-stage trial with 175 participants, so results may not apply to everyone. The treatments involve procedures and medications that carry risks like side effects or discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 175 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anesthesiology Pain Medicine Center
RECRUITINGChicago, Illinois, 60611, United States
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Walter Reed National Military Medical Center
RECRUITINGBethesda, Maryland, 20889, United States
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Womack Army Medical Center
NOT_YET_RECRUITINGFort Bragg, North Carolina, 28310, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can community health workers help trauma survivors heal?
- Can a blood pressure drug rewrite trauma memories to ease fibromyalgia?
- Can adding social support to trauma therapy ease PTSD in youth?
- Can ketamine rewire fear memories to ease PTSD?
- Rewiring the mind after trauma: a new therapy aims to change how we process painful events