Actively Recruiting

Age: 18Years +
All Genders
ID04685772

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

Led by Northwell Health · Updated on 2024-11-12

25

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of corticosteroids for treating acute post-concussion headaches. This study aims to determine if corticosteroids can reduce headache frequency and intensity more than the current standard care. It also explores whether corticosteroid use can lessen other symptoms like vestibular issues, helping patients return sooner to school, work, or sports. This novel pilot project focuses on patients with post-concussion headaches, a condition lacking established treatment guidelines despite its high prevalence and associated disabling symptoms such as depression and sleep problems. Participants will receive a Methylprednisolone dose pack, a corticosteroid medication tapered over seven days with a specific daily dosing schedule starting at 24 mg on day one and decreasing to zero by day seven. The treatment is taken orally following detailed instructions. The study does not mention a placebo or comparator group, focusing instead on evaluating this medication's impact on post-concussion headaches during the treatment period. During the study, participants will be monitored over 12 weeks to assess changes in headache symptoms, overall post-concussion symptoms, quality of life through health questionnaires, and other medication use with pain tracking diaries. The primary outcome is the change in headaches one week after treatment starts. Secondary outcomes include symptom scores and quality of life measures at 12 weeks. Participants' adherence to the medication regimen and symptom changes will be carefully observed to understand corticosteroids' role in managing post-concussion headaches.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Willingness to comply with all study procedures and available for study duration
  • Male or female aged over 18 years
  • Ability to take oral medication and follow the study regimen
  • Experiencing post-concussive headache with severity greater than 5 out of 10 on pain scale
  • Headache lasting more than 4 hours per day
  • Headache occurring every day
  • Headache started after concussion diagnosis at outpatient clinic or hospitalization
  • Headache developed within 7 days post-injury and presenting within 30 days from trauma
  • Diagnosed with concussion
  • Taking other pain medication is allowed
Not Eligible

You will not qualify if you...

  • Known intracranial hemorrhage seen on neuroimaging
  • Headache starting after 7 days post-injury or presenting after 30 days from trauma
  • Headache lasting less than 4 hours per day
  • Headache not occurring daily
  • Age 18 years or younger
  • Headache severity less than 5 on pain scale
  • Signs of increased intracranial pressure or papilledema
  • Contraindications or allergy to corticosteroids
  • Active tuberculosis or fungal infection
  • Active pregnancy
  • Currently using corticosteroids for other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 7 days

Participants take the Medrol Dose Pack, a corticosteroid medication tapered over 7 days to treat post-concussive headaches.

1 baseline visit and daily medication administration at home

Long-term Monitoring

Duration - 12 weeks

Participants are monitored for changes in headache symptoms and overall health for up to 12 weeks after treatment.

Periodic follow-up visits over 12 weeks

Trial Site Locations

Total: 1 location

1

Northwell Health - North Shore University Hospital

Manhasset, New York, United States, 11030

Actively Recruiting

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Research Team

J

Jamie Ullman, MD

B

Betsy Moclair, RN, CCRC

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Mild Traumatic Brain Injury and Post-concussion Syndrome: Treatment and Related Sequela for Persistent Symptomatic Disease.

Harry Bramley, Justin Hong, Christopher Zacko...

https://pubmed.ncbi.nlm.nih.gov/27482778

The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability.

N S King, S Crawford, F J Wenden...

https://pubmed.ncbi.nlm.nih.gov/8551320