Evaluating Medrol Dose Pack for treating headaches after concussions

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

This study is testing if a medication called Medrol can help people with headaches after a concussion feel better and get back to their normal activities faster.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 1 site (Manhasset, New York)
• Trial ID: NCT04685772 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of corticosteroids, specifically the Medrol Dose Pack, in reducing the frequency and intensity of acute post-concussive headaches. The investigators hypothesize that corticosteroid treatment will not only alleviate headaches but also decrease other related symptoms, facilitating a quicker return to normal activities such as school, work, or sports. The study is novel as it focuses on individuals suffering from post-concussion headaches, a condition that currently lacks established treatment guidelines. Participants will be monitored for their response to the medication over a specified period.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who experience daily headaches of significant severity following a concussion.

Not a fit: Patients with known intracranial hemorrhage or those whose headaches do not meet the study criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from debilitating post-concussive headaches.

How similar studies have performed: While corticosteroids have been studied in severe traumatic brain injury, this specific approach for post-concussive headaches is novel and has not been extensively tested.

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

Where this trial is running

Manhasset, New York

• Northwell Health - North Shore University Hospital — Manhasset, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Jamie S Ullman, MD — Hofstra Northwell School of Medicine
• Study coordinator: Jamie Ullman, MD

Conditions: Post-Concussion Syndrome, Headache, Methylprednisolone, Medrol Dose Pack, Steroid