Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Military Servicemembers are at elevated risk for traumatic brain injury (TBI) and its consequences, including post-traumatic headache (PTH). The most common phenotype of PTH is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. Therefore, the consideration of other methods to manage PTH in Servicemembers and Veterans is warranted. Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. This intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden. The acute burning that occurs during injection and then the numbing over the scalp that occurs shortly after anesthetic GON blockade make controlled investigations against placebo difficult to interpret. In sub-study 1 of this project, different concentrations of bupivacaine (0.0%, 0.01%, 0.05%, 0.1%) will be examined in order to identify a suitable control dose to later compare to the full dose of 0.5%. Acute and subacute sensations from bupivacaine GON blockade will be measured and the lowest concentration that resembles the sensations elicited by full dose (0.5%) will be used in a subsequent efficacy trial (sub-study 2). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06069791
Study type Interventional
Source Yale University
Contact Emmanuelle Schindler, MD, PhD
Phone 203-932-5711
Email emmanuelle.schindler@va.gov
Status Recruiting
Phase Phase 1
Start date January 26, 2024
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04369729 - Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache
Completed NCT03588364 - The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine N/A
Recruiting NCT05378074 - Hypersensitivity to Opening of BKCa Channels in Post-Traumatic Headache N/A
Recruiting NCT05328635 - Post-traumatic Headache Multidisciplinary Study
Completed NCT04776304 - Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms N/A
Recruiting NCT04614922 - Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms N/A
Recruiting NCT05595993 - Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache N/A
Completed NCT03674398 - Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology N/A
Completed NCT02965027 - Prazosin for Post-Concussive Headaches Phase 4
Active, not recruiting NCT05635656 - Digital Solutions for Concussion N/A
Recruiting NCT06015451 - Exercise in Postconcussion Symptoms and Posttraumatic Headache N/A
Recruiting NCT04906603 - Theta Burst Stimulation for Headaches After Traumatic Brain Injury N/A
Terminated NCT01053507 - Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction Phase 4
Completed NCT02419131 - Cognitive-Behavior Therapy for Posttraumatic Headache N/A
Terminated NCT03806985 - Effects of Psilocybin in Concussion Headache Phase 1
Completed NCT05243953 - Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache N/A
Completed NCT03056352 - Metoclopramide for Post-Traumatic Headache. A Pilot Study Phase 1/Phase 2
Recruiting NCT06132529 - A Study to Evaluate Biomarker Signature to Predict the Persistence of Post-traumatic Headache
Completed NCT01854385 - Sumatriptan as Treatment for Post-traumatic Headache Phase 2
Completed NCT03523923 - TBI Care: Collaborative Care for Pain After Traumatic Brain Injury (TBI) N/A