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NCT Number: NCT04685772

Assessment of the Efficacy of Medrol Dose Pack for Acute 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwell Health - North Shore University Hospital

Manhasset, New York, 11030, United States

Location status: Recruiting

Location contact

Betsy Moclair, RN, CCRC

CONTACT

[email protected]

(516) 253-7753

Dana Klavansky, MD

SUB_INVESTIGATOR

Jamie Ullman, MD

CONTACT

[email protected]

516-562-4300

Luca Giliberto, MD

SUB_INVESTIGATOR

Robert Duarte, MD

SUB_INVESTIGATOR

Rosanna Sabini, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form (in person or via telehealth)
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged >18 years old
  • Ability to take oral medication and be willing to adhere to the study regimen as described in this protocol
  • Patients presenting with all types of post-concussive headache with >5/10 in severity on the numerical analog scale.
  • Headache that occurs for > 4 hours per day
  • Headache that occurs every day
  • Headache that began after concussion, patient was diagnosed at an outpatient clinic or was hospitalized
  • Headache developed within 7 days post-injury and patient presenting within 30 days from initial trauma
  • A diagnosis of concussion.
  • If a patient is taking another pain medication, this still be included in the stud

Exclusion criteria

  • Any evidence of known intracranial hemorrhage on neuroimaging
  • Headache developing after 7 days post injury and patient presenting after 30 days from initial trauma
  • Headache occurs < 4 hours per day
  • Headache does not occur daily
  • Age < or = 18
  • Headache is < 5 in severity on numerical analog scale
  • Presence of increase in intracranial pressure or papilledema
  • Any contraindication to corticosteroids
  • Allergy or sensitivity to corticosteroids
  • Active Tuberculosis
  • Active pregnancy
  • Currently on corticosteroids for another reason
  • Participants with fungal infection

Treatment and study plan

methylprednisolone

Drug

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

Other names: No methylprednisolone

Primary outcomes

  1. Change in headaches

    Time frame: 1 Week

    Defined as change in headache in response to medication

Secondary outcomes

  1. 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.

  2. 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)

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Betsy Moclair, RN, CCRC

CONTACT

[email protected]

(516) 253-7753

Jamie Ullman, MD

CONTACT

[email protected]

(516) 562 4300

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 28, 2020
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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