RECRUITING

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

Conditions

Post-Concussion Syndrome Headache Methylprednisolone Medrol Dose Pack Steroid

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-01

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04685772

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Jamie Ullman, MD

CONTACT

(516) 562 4300

Jullman1@northwell.edu

Betsy Moclair, RN, CCRC

CONTACT

(516) 253-7753

bmoclair@northwell.edu

Principal Investigator

Jamie S Ullman, MD

PRINCIPAL_INVESTIGATOR

Hofstra Northwell School of Medicine

Study Locations (Sites)

Northwell Health - North Shore University Hospital

Manhasset, New York, 11030

United States

Collaborators and Investigators

Sponsor: Northwell Health

Jamie S Ullman, MD, PRINCIPAL_INVESTIGATOR, Hofstra Northwell School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2021-04-01

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

Methylprednisolone
Medrol Dose Pack
Steroid

Additional Relevant MeSH Terms

Post-Concussion Syndrome
Headache