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New treatment option for Posttraumatic Headache
Official title Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD
ClinicalTrials.gov ID: NCT06608277
What this study is testing
What is Group B active comparator?
Group B active comparator is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for posttraumatic headache.
Also referred to as Group B.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Duration of chronic TBI or PTSD \> 3 months
You likely can't join if
- 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)
See the full eligibility criteria
- 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...
- Duration of chronic TBI or PTSD \> 3 months
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Fort Bragg, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Bethesda, Maryland, United States; Fort Bragg, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.