Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT04051203
Eligibility Criteria:
Inclusion Criteria:
* Eligible participants will be males or females at least 18 years of age who suffer from post-traumatic headaches secondary to GON. Patients must fulfill the ICHD-3 criteria in establishing a diagnosis of GON. This diagnosis will be established by an experienced Physiatrist with extensive experience in headache and related disorders. To meet this criteria, patients must have experienced previous successful temporary relief with local anesthetic or steroid injection surrounding the GON in the past, but have not received local steroid injection within past 3 months. Pre-treatment numerical pain rating scale for daily headache intensity must be ≥4/10, with a headache frequency ≥10 days/month. Possible secondary causes of ON must be ruled out with reasonable level of investigation prior to enrollment.
Exclusion Criteria:
* Inability to provide informed consent; history of surgery in the occipital region; unstable psychiatric or medical condition; rheumatologic or inflammatory disorders; widespread neurologic disorders (eg. MS); coagulopathy; immunosuppression; active cancer; herpes zoster infection in last 6 months; pregnancy; steroid or other local GON or LON infiltration in past 3 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04051203
Study Brief:
Protocol Section:
NCT04051203