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Could a nerve block or ketamine ease PTSD and headaches after brain injury?

NCT ID NCT06608277

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 175 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Post-Traumatic Headache post-traumatic stress disorder

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Anesthesiology Pain Medicine Center

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Walter Reed National Military Medical Center

    RECRUITING

    Bethesda, Maryland, 20889, United States

  • Womack Army Medical Center

    NOT_YET_RECRUITING

    Fort Bragg, North Carolina, 28310, United States

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