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 Criteria:

  1. Provision of signed and dated informed consent form (in person or via telehealth)
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged >18 years old
  4. Ability to take oral medication and be willing to adhere to the study regimen as described in this protocol
  5. Patients presenting with all types of post-concussive headache with >5/10 in severity on the numerical analog scale.
  6. Headache that occurs for > 4 hours per day
  7. Headache that occurs every day
  8. Headache that began after concussion, patient was diagnosed at an outpatient clinic or was hospitalized
  9. Headache developed within 7 days post-injury and patient presenting within 30 days from initial trauma
  10. A diagnosis of concussion.
  11. If a patient is taking another pain medication, this still be included in the stud

Exclusion Criteria:

  1. Any evidence of known intracranial hemorrhage on neuroimaging
  2. Headache developing after 7 days post injury and patient presenting after 30 days from initial trauma
  3. Headache occurs < 4 hours per day
  4. Headache does not occur daily
  5. Age < or = 18
  6. Headache is < 5 in severity on numerical analog scale
  7. Presence of increase in intracranial pressure or papilledema
  8. Any contraindication to corticosteroids
  9. Allergy or sensitivity to corticosteroids
  10. Active Tuberculosis
  11. Active pregnancy
  12. Currently on corticosteroids for another reason
  13. 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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Page 1 of 1 (1 locations)

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Northwell Health - North Shore University Hospital

Manhasset, New York, United States, 11030

Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches | DecenTrialz