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New treatment option for Post-Traumatic Headache
Official title Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1
ClinicalTrials.gov ID: NCT06069791
What this study is testing
What is Bupivacaine Injection?
Bupivacaine Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for post-traumatic headache.
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
- The acute and subacute sensations that occur on the scalp with injection of different concentrations of bupivacaine for grater occipital nerve blockade will be compared. Each Veteran participant will be randomized to receive three different concentrations, which will be injected one week apart each.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- United States Military Veterans within VA Connecticut Healthcare System
- Chronic post-traumatic headache per ICHD-3 criteria (i.e., headaches are continuing to occur three months after the head injury)
- At least two headache days per week
- MRI brain scan completed within the past 3 months if chronic PTH for less than one year, within the past year if chronic PTH for less than 5 years...
- Review of MRI and the medical record does not reveal another source for headache
You likely can't join if
- Skull defect
- Other contraindication to bupivacaine
- Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine
- Instruction from clinician to avoid amide anesthetics, such as lidocaine
- Pregnant or lack of adequate birth control
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, 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 West Haven, Connecticut, 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.