Recruiting

Corticosteroids

Sponsor:

Northwell Health

Code:

NCT04685772

Conditions

Post-Concussion Syndrome

Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methylprednisolone

Study Details

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 significant headache reduction in frequency and/or intensity than individuals who undergo the current standard of care. Additionally, the investigators hypothesize that corticosteroid use will lead to a reduction in other somatic symptoms including vestibular symptoms, leading to quicker return to school, work, and/or ability to play sports.

Conditions

Post-Concussion Syndrome

Headache

Study ID

NCT04685772

Start date

Apr 1, 2021

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Interventions

Methylprednisolone

The Methylprednisolone dose pack (Medrol Dose Pack) is pre-packaged with dosing instructions. This dose pack is tapered over 7 days and administration will be the following for all patients:

Day 1 (total 24 milligrams (mg)) - 8mg before breakfast, 4mg after lunch and dinner, and 8mg at bedtime Day 2 (total 20mg) - 4mg before breakfast, after lunch and dinner, and 8mg at bedtime Day 3 (total 16mg) - 4mg before breakfast, lunch, dinner, and at bedtime Day 4 (total 12mg) - 4mg before breakfast, after lunch, and at bedtime Day 5 (total 8mg) - 4mg before breakfast and at bedtime Day 6 (total 4mg) - 4mg before breakfast Day 7 (total 0mg) - Completed

Primary outcome measure

  • Change in headaches [ Time Frame: 1 Week ]

Central Contacts and Locations

Central contacts

Locations

Northwell Health - North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

More Information

Sponsor

Northwell Health

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Methylprednisolone
  • Medrol Dose Pack
  • Steroid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-08-26.