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

May 5, 2023 updated by: Northwell Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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) setting but none have been completed on individuals who suffer post-concussion headaches. Despite a high prevalence of post-concussive headache, there are no evidence-based guidelines for acute or preventive pharmacological treatment. Patients who experience very frequent or daily headache post-concussive headache are also at risk of developing medication-overuse headache (MOH)12. In addition, patients with post-concussive headache experience disabling comorbidities such as symptoms of depression, anxiety, and sleep disturbances 12 This study will be of benefit to patients who suffer headaches after a concussion because, though various treatments have been studied, including a combination of Reglan and Benadryl (63% effective in one prospective study) triptans vs non-triptans (70% effective vs 42% effective in one retrospective trial), gabapentin vs tricyclic antidepressants vs. no medication (no significant difference in outcome), none have been established as a definitive treatment regimen for post-concussive headache 12. Corticosteroids are currently utilized for management of these headaches; they are done so at the discretion of the physician and like the aforementioned medications, are not standard of care. Corticosteroid used in severe TBI (GCS < 8) have been widely studied8, however the utility has not been conclusive. Of note, case studies in the pediatric population with mild TBI (GCS 13-15) and post-concussive headache, report that they respond well to the Medrol Dose Pack with headache improvement during or after completion of the medication2. Currently, there is no standard treatment of post-concussion headaches, and in clinical practice, it has been observed that only approximately 50% of patients improve without any medication use. It is important to establish the role of corticosteroids in treating post-concussive headaches because they may improve quality of life and accelerate patient's functional recovery.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health - North Shore University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dana Klavansky, MD
        • Sub-Investigator:
          • Robert Duarte, MD
        • Sub-Investigator:
          • Rosanna Sabini, MD
        • Sub-Investigator:
          • Luca Giliberto, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in headaches
Time Frame: 1 Week
Defined as change in headache in response to medication
1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total Post Concussion Symptom (0-120) scores over time
Time Frame: 12 weeks
change in the NEW total PCSS score from baseline (day0) to week 1, to week 4 and to week 12; Higher scores indicate worse symptoms.
12 weeks
EQ-5D (Euro Qual Health State Questionnaire) score changes (1-100 in each category); higher score indicates better state of health in several domains.
Time Frame: 12 weeks
EQ-5D score in the categories of 'Usual Activities' and 'Pain/Discomfort' of the EQ-5D Health Questionnaire between visit 1 (day 7) and visit 5(week 11/12)
12 weeks
Diary of other medication use and pain level
Time Frame: 12 weeks
Secondary outcome 9: Each patient will be asked to keep a daily diary, recording pain medications used and a pain level (in a scale of 0-10).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Jamie S Ullman, MD, Hofstra Northwell School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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