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NCT Number: NCT07796074

Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 2

Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects. In this study, Veterans with post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks and the lasting (i.e., transitional) effects on headache frequency measured in a headache diary.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location status: Recruiting

Location contact

Emmanuelle Schindler, MD, PhD

CONTACT

[email protected]

203-932-5711 ext. 14335

About this study

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.

In this second portion of this study, Veterans with chronic post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks. They will maintain a headache diary to measure the change in headache frequency over the two months after injection. This design uses information gathered from sub-study 1 of this project (NCT#06069791). In that initial intervention, different concentrations of bupivacaine were examined to consider the intensity and spread of acute and subacute sensations that occur with GON blockade. This allowed us to select a low dose (0.05%) that approximates the sensations of the full dose of 0.5%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • United States Military Veterans within VA Connecticut Healthcare System1.
  • Head injury with headaches that have continued to occur for at least three months after the head injury
  • At least two headache days per week
  • Review of the medical record does not reveal another source for headache

Exclusion criteria

  • 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
  • Clinical review of the patient's case reveals red flag signs or symptoms (e.g., side-locked pain, unilateral numbness/weakness during headache, rapid ascension to peak pain, syncope during attacks) that warrant further work-up (e.g., MRI, arterial imaging).
  • Absence of imaging warranted by the standard of clinical care for the head injury with headaches.

Treatment and study plan

Bupivacaine bilateral greater occipital nerve block

Other

Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.

Primary outcomes

  1. Change in headache days/week in the first month

    Time frame: From one month before to one month after injection

    Change in the weekly number of headache days after GON blockade

Secondary outcomes

  1. Change in headache days/week over two months

    Time frame: From one month before to two months after injection

    Change in number of days per week with headache

  2. Change in average headache pain intensity

    Time frame: From one month before to two months after injection

    Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)

  3. Change in average attack duration

    Time frame: From one month before to two months after injection

    Hours

  4. Change in average headache-associated light sensitivity

    Time frame: From one month before to two months after injection

    Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)

  5. Change in average headache-associated sound sensitivity

    Time frame: From one month before to two months after injection

    Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)

  6. Change in average headache-associated nausea/vomiting

    Time frame: From one month before to two months after injection

    Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)

  7. Change in average headache-associated functional impairment

    Time frame: From one month before to two months after injection

    Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)

  8. Change in average days/week using headache abortive treatment

    Time frame: From one month before to two months after injection

    Number of days per week using an abortive treatment for headache

  9. Patient Global Impression of Change scale (PGIC)

    Time frame: From one month before to two months after injection

    PGIC score

  10. Migraine-Specific Quality of Life questionnaire (v2.1) (MSQ)

    Time frame: From one month before to two months after injection

    MSQ score

  11. Migraine Disability Assessment (MIDAS)

    Time frame: From one month before to two months after injection

    MIDAS score

  12. Adverse events

    Time frame: From one month before to two months after injection

    Complications that occur during or after injection

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuelle Schindler, MD, PhD

CONTACT

[email protected]

203-932-5711 ext. 14335

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Headache Foundation
  • VA Connecticut Healthcare System

Registry information

Official study title

Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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