Treatment for Post-concussive Headache: A Randomized, Placebo-controlled, Double Blinded Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Post-Concussive Symptom Inventory (PSCI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental
10mg capsule once daily for 4 weeks of nortriptyline
干预措施: Nortriptyline (Drug)
Control
10mg capsule once daily for 4 weeks of Thick-It filler
干预措施: Placebo (Drug)
结局指标
主要结局
Post-Concussive Symptom Inventory (PSCI) Score
时间窗: 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.
次要结局
未报告次要终点