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Standard of Care plus Education for Headache Disorders

N/A
Waitlist Available
Led By Andrew Baker
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be diagnosed with a chronic ( between 2 and 4 months post injury) mTBI based on CDC criteria. They must have the ability to give consent, speak English with awareness that they will need to be contacted at various time points, and must have access to email. There will be inclusion of patients who score 3 or more on the RPQ during their initial assessment in the St. Michael's Head Injury Clinic. They must be medically stable.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

The study will ask the question as to whether or not it is possible to deliver education material to patients with a mild traumatic brain injury in a consistent matter. The question will be asked as to whether an educational intervention decreases symptom reporting specifically looking at headache symptoms. Half of the patients will receive the current standard of care in the tertiary clinic they have been referred to while the other half will also receive the current standard of care with the addition of targeted headache educational material at various time points.

Eligible Conditions
  • Headache Disorders
  • Concussion
  • Post-Concussion Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survey response
Secondary outcome measures
Access to health care
Perceived quality of life
Brain Concussion
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care plus EducationExperimental Treatment1 Intervention
Educational material will be provided at three time points along with the current standard of care provided in tertiary health care setting
Group II: Standard of CareActive Control1 Intervention
Current standard of care provided in tertiary health care setting

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
537 Previous Clinical Trials
447,469 Total Patients Enrolled
Andrew BakerPrincipal InvestigatorUnity Health Toronto
2 Previous Clinical Trials
78 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
2018. "Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03391583.
All > Tbi > Traumatic Brain Injury
~10 spots leftby Apr 2025
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