Symptom-specific Headache Treatment for Brain Injuries

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Calgary, Calgary, Canada
Brain Injuries+11 More
Symptom-specific Headache Treatment - Procedure
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

Given the rising rates of concussion in youth ages 10-19 and the significant proportion of young people who remain symptomatic for months following concussion, research evaluating the efficacy of multifaceted treatment options following concussion is imperative. Studies examining the efficacy of treatment strategies following concussion in children and adults are surprisingly limited, and most focus on one treatment approach, have small sample sizes, are not randomized controlled trials, and focus on individuals with prolonged recovery (months). There is a need for a multifaceted treatment trial to examine the early implementation of treatment approaches that may reduce prolonged recovery while considering the heterogeneous presentation of symptoms and patient preferences in the sub-acute stage following concussion. Randomized controlled trials that consider a multifaceted transdisciplinary approach to treatment in the early period following concussion are needed to raise the bar regarding evidence-informed management following concussion

Eligible Conditions

  • Brain Injuries
  • Mild Traumatic Brain Injury (MTBI)
  • Headache
  • Sleep Disturbance

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Measured until 3 months from the start of treatment

Week 6
Change in symptoms
Week 6
Change in quality of life rating
Change in resilience
Change in symptoms on the Buffalo Concussion Treadmill Test
Changes in symptom-specific ratings
Month 3
Return to unrestricted physical activity

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Dizziness and/or Neck Pain Treatment
1 of 4
Headache Treatment
1 of 4
Sleep Disturbance Treatment
1 of 4
Generic, Multi-faceted Treatment
1 of 4
Experimental Treatment

294 Total Participants · 4 Treatment Groups

Primary Treatment: Symptom-specific Headache Treatment · No Placebo Group · Phase 3

Dizziness and/or Neck Pain Treatment
Other
Experimental Group · 1 Intervention: Symptom-specific Dizziness &/or Neck Pain Treatment · Intervention Types: Other
Headache Treatment
Procedure
Experimental Group · 1 Intervention: Symptom-specific Headache Treatment · Intervention Types: Procedure
Sleep Disturbance Treatment
Behavioral
Experimental Group · 1 Intervention: Symptom-specific Sleep Disturbance Treatment · Intervention Types: Behavioral
Generic, Multi-faceted Treatment
Behavioral
Experimental Group · 1 Intervention: Generic Concussion Treatment · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured until 3 months from the start of treatment
Closest Location: University of Calgary · Calgary, Canada
Photo of Calgary 1Photo of Calgary 2Photo of Calgary 3
2004First Recorded Clinical Trial
4 TrialsResearching Brain Injuries
271 CompletedClinical Trials

Who is running the clinical trial?

University of CalgaryLead Sponsor
692 Previous Clinical Trials
449,535 Total Patients Enrolled
13 Trials studying Brain Injuries
55,656 Patients Enrolled for Brain Injuries
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,216 Previous Clinical Trials
24,391,720 Total Patients Enrolled
16 Trials studying Brain Injuries
10,485 Patients Enrolled for Brain Injuries

Eligibility Criteria

Age < 65 · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with a concussion by the study physician.
You have symptoms of dizziness, neck pain, headaches, or sleep disturbance at > one week and < three weeks post injury reported on the PCSS (3-6 on 0-6 Likert scale for at least one of three symptoms).
You are under the age of 19.
You have a Glasgow Coma Scale score of 13-15 if recorded.
You have been diagnosed with a suspected case of infection in the 2 weeks following the injury.
You have a history of migraine or a family history of migraine.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.