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Could a 7-Day steroid course tame Post-Concussion headaches?

NCT ID NCT04685772

Symptom relief Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This pilot trial tests whether a short course of the steroid methylprednisolone, given as a tapering dose pack over 7 days, can reduce the frequency and intensity of headaches that follow a concussion. Adults with post-concussion headaches rated at least 5 out of 10 in severity are being studied, with changes in headache and other concussion symptoms tracked over 12 weeks. The goal is to see if this treatment could offer faster relief and a quicker return to daily activities compared with standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methylprednisolone, a corticosteroid taken as a 7-day tapering dose pack
What this could lead to
If it works, this could point toward a simple, short-term treatment to reduce post-concussion headaches and help people return to school, work, or sports sooner.
What could go wrong
This is a small pilot study, so results may not apply broadly. Steroids can have side effects, and the benefit over standard care is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who meet the inclusion criteria will be consented for the study. Patients will be recruited when they follow up on their initial appointment after hospitalization

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Headache headache disorder Post-Concussion Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Headache Post-concussion syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Northwell Health - North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

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