Pediatric Concussion Outcomes

Study Overview
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Brief Summary
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This is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline. Each group will be evaluated at week 0 and again each week for the next 4 weeks of treatment with a concussion survey that rates their symptoms. At the end of 4 weeks the study will be unblinded. It is hypothesized that the addition of nortriptyline to the standard headache treatments will result in more rapid decrease of symptom score than with placebo.

Official Title
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Treatment for Post-concussive Headache: A Randomized, Placebo-controlled, Double Blinded Trial

Conditions
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Concussion Post Syndrome, Headaches Posttraumatic, Mild Traumatic Brain Injury

Intervention / Treatment
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* Drug: Nortriptyline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Participants aged 13-21 years old In good general health as evidenced by medical history and diagnosed with recent head trauma meeting ICHD-3 criteria for acute posttraumatic headache with symptom onset < 7 days from trauma Ability to take oral medication and be willing to adhere to the medication regimen No loss of consciousness OR loss of consciousness <30 minutes Headache symptoms persisting ≥4 weeks post trauma PCSHE score for headache + pressure in head + neck pain must be > 3 After week 4 post-concussion at time of enrollment Not currently receiving pharmacologic treatment for concussion asid from NSAIDs and acetaminophen Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Focal neurological deficits following injury Any acute abnormality on Computed Tomography (if obtained) History of known seizure disorder or moderate or severe TBI Current uncontrolled psychiatric illness given the potential side effects of the study drug (at investigator discretion). Current suicidal ideation as screened for on PHQ on intake A personal history of Brugada syndrome Known allergic reaction to nortriptyline Current pregnancy Positive COVID-19 test in prior 14 days

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>10mg capsule once daily for 4 weeks of nortriptyline | Drug: Nortriptyline<br>* 10mg capsule Nortryptyline<br>* Other names: Pamelor;|
| Placebo Comparator: Control<br>10mg capsule once daily for 4 weeks of Thick-It filler | Drug: Placebo<br>* 10mg capsule Thick-It filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Concussive Symptom Inventory (PSCI) score | Post-Concussive Symptom Inventory (PSCI) score of 0-1 on the headache symptom, where the score ranges from 0 (absent) to 6 (severe). A score of 0 is optimal, while a score of 6 is not optimal. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concussion, headache, mild TBI, post concussion