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

Recruiting

• Conditions: Post-Concussion Syndrome; Headache

• Registration Number: NCT04685772
• Lead Sponsor: Northwell Health

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.

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 Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2021-04-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in headaches	1 Week	Defined as change in headache in response to medication

Secondary Outcome Measures

Name	Time	Method
EQ-5D (Euro Qual Health State Questionnaire) score changes (1-100 in each category); higher score indicates better state of health in several domains.	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)
Change in total Post Concussion Symptom (0-120) scores over time	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.
Diary of other medication use and pain level	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).

Trial Locations

Locations (1)

Northwell Health - North Shore University Hospital; 🇺🇸 Manhasset, New York, United States