Concussion Post Syndrome, Headaches Posttraumatic, Mild Traumatic Brain Injury
Conditions
Keywords
concussion, headache, mild TBI, post concussion
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.
Detailed description
Participants are randomly assigned to one of two treatment groups. The experimental group receives standard headache treatment including Tylenol, NSAIDs 2-3x/week, vestibular PT and daily nortriptyline 10mg oral. The control group also receives the standard headache treatment, but will instead be given a placebo, which will look physically identical to the nortriptyline capsule and be comprised of non-active pharmaceutical grade excipient.
Interventions
DRUGNortriptyline
10mg capsule Nortryptyline
DRUGPlacebo
10mg capsule Thick-It filler
Sponsors
Lancaster General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Participants aged 13-21 years old 4. 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 5. Ability to take oral medication and be willing to adhere to the medication regimen 6. No loss of consciousness OR loss of consciousness \<30 minutes 7. Headache symptoms persisting ≥4 weeks post trauma 8. PCSHE score for headache + pressure in head + neck pain must be \> 3 9. After week 4 post-concussion at time of enrollment 10. 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: 1. Focal neurological deficits following injury 2. Any acute abnormality on Computed Tomography (if obtained) 3. History of known seizure disorder or moderate or severe TBI 4. Current uncontrolled psychiatric illness given the potential side effects of the study drug (at investigator discretion). 5. Current suicidal ideation as screened for on PHQ on intake 6. A personal history of Brugada syndrome 7. Known allergic reaction to nortriptyline 8. Current pregnancy 9. Positive COVID-19 test in prior 14 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Concussive Symptom Inventory (PSCI) Score | 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental 10mg capsule once daily for 4 weeks of nortriptyline
Nortriptyline: 10mg capsule Nortryptyline | 4 |
| Control 10mg capsule once daily for 4 weeks of Thick-It filler
Placebo: 10mg capsule Thick-It filler | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Experimental | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.5 years STANDARD_DEVIATION 2 | 14.7 years STANDARD_DEVIATION 1 | 14.6 years STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 2 / 4 | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
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.
Time frame: 4 weeks
Population: The trial was terminated before the outcome measure data were collected.