Status:
RECRUITING
Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches
Lead Sponsor:
Northwell Health
Conditions:
Post-Concussion Syndrome
Headache
Eligibility:
All Genders
18+ years
Brief Summary
This novel pilot project will assess the effectiveness of corticosteroids in treatment of acute post-concussion headache. The investigators hypothesize that the use of corticosteroids will cause signi...
Detailed Description
To the best of the investigators' knowledge, this is a novel study. Studies have been previously done on individuals who have suffered an acute TBI and were admitted to an intensive care unit (ICU) se...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form (in person or via telehealth)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged \>18 years old
- Ability to take oral medication and be willing to adhere to the study regimen as described in this protocol
- Patients presenting with all types of post-concussive headache with \>5/10 in severity on the numerical analog scale.
- Headache that occurs for \> 4 hours per day
- Headache that occurs every day
- Headache that began after concussion, patient was diagnosed at an outpatient clinic or was hospitalized
- Headache developed within 7 days post-injury and patient presenting within 30 days from initial trauma
- A diagnosis of concussion.
- If a patient is taking another pain medication, this still be included in the stud
Exclusion
- Any evidence of known intracranial hemorrhage on neuroimaging
- Headache developing after 7 days post injury and patient presenting after 30 days from initial trauma
- Headache occurs \< 4 hours per day
- Headache does not occur daily
- Age \< or = 18
- Headache is \< 5 in severity on numerical analog scale
- Presence of increase in intracranial pressure or papilledema
- Any contraindication to corticosteroids
- Allergy or sensitivity to corticosteroids
- Active Tuberculosis
- Active pregnancy
- Currently on corticosteroids for another reason
- Participants with fungal infection
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04685772
Start Date
April 1 2021
End Date
December 1 2026
Last Update
November 12 2024
Active Locations (1)
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1
Northwell Health - North Shore University Hospital
Manhasset, New York, United States, 11030