Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04685772
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2020-12-22
Brief Title:
Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Assessment of the Efficacy of Medrol Dose Pack for Post-Concussive Headaches
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 MOH12 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 patients functional recovery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None