Post-Concussion SyndromeNCT04685772
Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches
An observational study of Post-Concussion Syndrome and Headache, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Concussion Syndrome, Headache
- What is being tested?
- Methylprednisolone
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwell Health - North Shore University Hospital
Manhasset, New York, 11030
Jamie Ullman, MD, 516-562-4300, jullman1@northwell.edu
Betsy Moclair, RN, CCRC, (516) 253-7753, bmoclair@northwell.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Methylprednisolone
- Keywords
- Methylprednisolone, Medrol Dose Pack, Steroid
- Medical subject headings
- Post-Concussion Syndrome, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called No 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headaches
Defined as change in headache in response to medication
Measured: 1 Week
Secondary outcomes (3)
Change in total Post Concussion Symptom (0-120) scores over time
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.
Measured: 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.
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)
Measured: 12 weeks
Diary of other medication use and pain level
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Apr 2021
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie S Ullman, MD, Principal investigator, Hofstra Northwell School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685772
- Sponsor's protocol ID
- 20-1092
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bulamu NB, Kaambwa B, Ratcliffe J. A systematic review of instruments for measuring outcomes in economic evaluation within aged care. Health Qual Life Outcomes. 2015 Nov 9;13:179. doi: 10.1186/s12955-015-0372-8.
PubMed 26553129Bramley H, Hong J, Zacko C, Royer C, Silvis M. Mild Traumatic Brain Injury and Post-concussion Syndrome: Treatment and Related Sequela for Persistent Symptomatic Disease. Sports Med Arthrosc Rev. 2016 Sep;24(3):123-9. doi: 10.1097/JSA.0000000000000111.
PubMed 27482778Bramley H, Melinosky C, Silvis M, Ross S. Pediatric posttraumatic headache: two cases using steroids as abortive therapy. Pediatr Emerg Care. 2012 Oct;28(10):1081-4. doi: 10.1097/PEC.0b013e31826ceeeb.
PubMed 23034499Cushman DM, Borowski L, Hansen C, Hendrick J, Bushman T, Teramoto M. Gabapentin and Tricyclics in the Treatment of Post-Concussive Headache, a Retrospective Cohort Study. Headache. 2019 Mar;59(3):371-382. doi: 10.1111/head.13451. Epub 2018 Nov 19.
PubMed 30451286Ducic I, Sinkin JC, Crutchfield KE. Interdisciplinary treatment of post-concussion and post-traumatic headaches. Microsurgery. 2015 Nov;35(8):603-7. doi: 10.1002/micr.22503. Epub 2015 Sep 26.
PubMed 26409037EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801Halstead ME. Pharmacologic Therapies for Pediatric Concussions. Sports Health. 2016 Jan-Feb;8(1):50-2. doi: 10.1177/1941738115622158.
PubMed 26660460Hoshide R, Cheung V, Marshall L, Kasper E, Chen CC. Do corticosteroids play a role in the management of traumatic brain injury? Surg Neurol Int. 2016 Sep 13;7:84. doi: 10.4103/2152-7806.190439. eCollection 2016.
PubMed 27656315Kacperski J. Pharmacotherapy for Persistent Posttraumatic Headaches in Children and Adolescents: A Brief Review of the Literature. Paediatr Drugs. 2018 Oct;20(5):385-393. doi: 10.1007/s40272-018-0299-8.
PubMed 29876872King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.
PubMed 8551320Kuczynski A, Crawford S, Bodell L, Dewey D, Barlow KM. Characteristics of post-traumatic headaches in children following mild traumatic brain injury and their response to treatment: a prospective cohort. Dev Med Child Neurol. 2013 Jul;55(7):636-41. doi: 10.1111/dmcn.12152. Epub 2013 Apr 5.
PubMed 23560811Larsen EL, Ashina H, Iljazi A, Al-Khazali HM, Seem K, Ashina M, Ashina S, Schytz HW. Acute and preventive pharmacological treatment of post-traumatic headache: a systematic review. J Headache Pain. 2019 Oct 21;20(1):98. doi: 10.1186/s10194-019-1051-7.
PubMed 31638888Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L, Ouchterlony D, Weegar K; mTBI Expert Consensus Group. Updated clinical practice guidelines for concussion/mild traumatic brain injury and persistent symptoms. Brain Inj. 2015;29(6):688-700. doi: 10.3109/02699052.2015.1004755. Epub 2015 Apr 14.
PubMed 25871303Potter S, Leigh E, Wade D, Fleminger S. The Rivermead Post Concussion Symptoms Questionnaire: a confirmatory factor analysis. J Neurol. 2006 Dec;253(12):1603-14. doi: 10.1007/s00415-006-0275-z. Epub 2006 Oct 24.
PubMed 17063314Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
PubMed 11491192
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Medrol Dose Pack for Post-Concussive Headaches
- ClinicalTrials.gov ID
- NCT04685772
- Acronym / sponsor ID
- 20-1092
- Conditions
- Post-Concussion Syndrome, Headache
- Keywords
- Methylprednisolone, Medrol Dose Pack, Steroid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneAlso: No methylprednisoloneThe 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 | Drug | – |
Primary outcome
Change in headaches
Time frame: 1 Week
Defined as change in headache in response to medication
3 secondary outcomes
Change in total Post Concussion Symptom (0-120) scores over time
Time frame: 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
Diary of other medication use and pain level
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 26553129Bulamu NB, Kaambwa B, Ratcliffe J. A systematic review of instruments for measuring outcomes in economic evaluation within aged care. Health Qual Life Outcomes. 2015 Nov 9;13:179. doi: 10.1186/s12955-015-0372-8.
- Background: PubMed 27482778Bramley H, Hong J, Zacko C, Royer C, Silvis M. Mild Traumatic Brain Injury and Post-concussion Syndrome: Treatment and Related Sequela for Persistent Symptomatic Disease. Sports Med Arthrosc Rev. 2016 Sep;24(3):123-9. doi: 10.1097/JSA.0000000000000111.
- Background: PubMed 23034499Bramley H, Melinosky C, Silvis M, Ross S. Pediatric posttraumatic headache: two cases using steroids as abortive therapy. Pediatr Emerg Care. 2012 Oct;28(10):1081-4. doi: 10.1097/PEC.0b013e31826ceeeb.
- Background: PubMed 30451286Cushman DM, Borowski L, Hansen C, Hendrick J, Bushman T, Teramoto M. Gabapentin and Tricyclics in the Treatment of Post-Concussive Headache, a Retrospective Cohort Study. Headache. 2019 Mar;59(3):371-382. doi: 10.1111/head.13451. Epub 2018 Nov 19.
- Background: PubMed 26409037Ducic I, Sinkin JC, Crutchfield KE. Interdisciplinary treatment of post-concussion and post-traumatic headaches. Microsurgery. 2015 Nov;35(8):603-7. doi: 10.1002/micr.22503. Epub 2015 Sep 26.
- Background: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
- Background: PubMed 26660460Halstead ME. Pharmacologic Therapies for Pediatric Concussions. Sports Health. 2016 Jan-Feb;8(1):50-2. doi: 10.1177/1941738115622158.
- Background: PubMed 27656315Hoshide R, Cheung V, Marshall L, Kasper E, Chen CC. Do corticosteroids play a role in the management of traumatic brain injury? Surg Neurol Int. 2016 Sep 13;7:84. doi: 10.4103/2152-7806.190439. eCollection 2016.
- Background: PubMed 29876872Kacperski J. Pharmacotherapy for Persistent Posttraumatic Headaches in Children and Adolescents: A Brief Review of the Literature. Paediatr Drugs. 2018 Oct;20(5):385-393. doi: 10.1007/s40272-018-0299-8.
- Background: PubMed 8551320King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.
- Background: PubMed 23560811Kuczynski A, Crawford S, Bodell L, Dewey D, Barlow KM. Characteristics of post-traumatic headaches in children following mild traumatic brain injury and their response to treatment: a prospective cohort. Dev Med Child Neurol. 2013 Jul;55(7):636-41. doi: 10.1111/dmcn.12152. Epub 2013 Apr 5.
- Background: PubMed 31638888Larsen EL, Ashina H, Iljazi A, Al-Khazali HM, Seem K, Ashina M, Ashina S, Schytz HW. Acute and preventive pharmacological treatment of post-traumatic headache: a systematic review. J Headache Pain. 2019 Oct 21;20(1):98. doi: 10.1186/s10194-019-1051-7.
- Medrol Dose Pack Product informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie S Ullman, MD principal investigator
Hofstra Northwell School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Concussion Syndrome and Headache, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Ullman, MD ((516) 562 4300, Jullman1@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headaches (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685772, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.