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Pediatric Concussion Outcomes (PeCon)

Primary Purpose

Concussion Post Syndrome, Headaches Posttraumatic, Mild Traumatic Brain Injury

Status

Enrolling by invitation

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Nortriptyline

Placebo

About this trial

This is an interventional treatment trial for Concussion Post Syndrome focused on measuring concussion, headache, mild TBI, post concussion

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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
Male or female, aged 13-18 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
Between weeks 4 and 12 post-concussion at time of enrollment
Agreement to avoid over the counter supplements
Agreement to adhere to 3x weekly dosing of NSAIDs to avoid rebound headache from overuse.
Patient of LGHP Sports Medicine who is currently playing an organized sport

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 abnormality on Computed Tomography (if obtained)
History of known neurological disorder (history of prior TBI, seizure disorder)
History of known psychiatric disease (ex. ADHD, anxiety, depression) given the potential side effects of the study drug.
Current suicidal ideation as screened for on PHQ-A on intake
Current treatment with antidepressants (unless a stable medical regimen is in place for at least 6 months per provider assessment)
A personal history of Brugada syndrome
Known allergic reaction to nortriptyline
Current pregnancy
Use of nortriptyline in prior 6 months
Positive COVID-19 test in prior 90 days

Sites / Locations

Penn Medicine Lancaster General Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

10mg capsule once daily for 4 weeks of nortriptyline

10mg capsule once daily for 4 weeks of Thick-It filler

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04226365

First Posted

January 9, 2020

Last Updated

August 16, 2022

Sponsor

Lancaster General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04226365

Brief Title

Pediatric Concussion Outcomes

Acronym

PeCon

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 15, 2020 (Actual)

Primary Completion Date

February 2, 2025 (Anticipated)

Study Completion Date

August 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lancaster General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Concussion Post Syndrome, Headaches Posttraumatic, Mild Traumatic Brain Injury

Keywords

concussion, headache, mild TBI, post concussion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

10mg capsule once daily for 4 weeks of nortriptyline

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

10mg capsule once daily for 4 weeks of Thick-It filler

Intervention Type

Drug

Intervention Name(s)

Nortriptyline

Other Intervention Name(s)

Pamelor

Intervention Description

10mg capsule Nortryptyline

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

10mg capsule Thick-It filler

Primary Outcome Measure Information:

Title

Post-Concussive Symptom Inventory (PSCI) score

Description

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.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Male or female, aged 13-18 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 Between weeks 4 and 12 post-concussion at time of enrollment Agreement to avoid over the counter supplements Agreement to adhere to 3x weekly dosing of NSAIDs to avoid rebound headache from overuse. Patient of LGHP Sports Medicine who is currently playing an organized sport 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 abnormality on Computed Tomography (if obtained) History of known neurological disorder (history of prior TBI, seizure disorder) History of known psychiatric disease (ex. ADHD, anxiety, depression) given the potential side effects of the study drug. Current suicidal ideation as screened for on PHQ-A on intake Current treatment with antidepressants (unless a stable medical regimen is in place for at least 6 months per provider assessment) A personal history of Brugada syndrome Known allergic reaction to nortriptyline Current pregnancy Use of nortriptyline in prior 6 months Positive COVID-19 test in prior 90 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Moreno, MD

Organizational Affiliation

Lancaster General Health Sports Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Laura DiPaolo, MD

Organizational Affiliation

Lancaster General Health Sports Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn Medicine Lancaster General Health

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17602

Country

United States

12. IPD Sharing Statement

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Pediatric Concussion Outcomes

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