NCT04685772

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Post-Concussion Syndrome
• Headache

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2020-12-28
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study