Status:
RECRUITING
Ketamine, SGB and Combination Treatment for TBI
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Walter Reed National Military Medical Center
Lviv National Medical University
Conditions:
Posttraumatic Headache
Posttraumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Detailed Description
This is a multicenter randomized, double-blind (subject, evaluator) placebo-controlled parallel-group clinical trial where 175 eligible subjects will be randomized into 1 of 4 groups (described below)...
Eligibility Criteria
Inclusion
- Adults 18 years or older
- Stable doses of medications for \> 2 weeks for TBI and/or PTSD
- 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.
- Duration of chronic TBI or PTSD \> 3 months
Exclusion
- Ketamine infusion or SGB within the past 6 months
- Serious medical or psychiatric conditions other than TBI or PTSD that could affect cognition (e.g., dementia, Parkinson's Disease)
- Elevated intracranial pressure
- For TBI, prior history of headache that can explain the headache intensity (i.e., headache not attributable to TBI)
- Active psychosis or poorly controlled non-injury or PTSD-related psychiatric condition (e.g., bipolar disorder)
- Poorly controlled medical conditions that could be exacerbated by treatment (e.g., unstable angina)
- Pregnancy (women of childbearing age who can become pregnant will have to take a pregnancy test)
- Non-fluency in English (poor generalizability to military and veteran populations, instruments not validated for use or translated in many languages)
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT06608277
Start Date
July 2 2025
End Date
April 30 2028
Last Update
August 26 2025
Active Locations (3)
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1
Anesthesiology Pain Medicine Center
Chicago, Illinois, United States, 60611
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
3
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310