Concussion Post Syndrome, Head Trauma Injury
Conditions
Keywords
Concussion, Head Trauma, Acetaminophen, Metoclopramide
Brief summary
The IMPACT study is a randomized, double-blind clinical trial evaluating two commonly used intravenous medications - metoclopramide and acetaminophen - for treating acute post-concussion symptoms in emergency department patients after mild head injury. The study aims to determine which treatment more effectively improves symptoms such as headache, dizziness, nausea, concentration difficulties, and emotional changes within the first week after injury. Participants will be enrolled across two Montefiore emergency departments and followed using a validated post-concussion symptom questionnaire. Findings from this study may help improve evidence-based treatment strategies for patients experiencing concussion-related symptoms after head trauma.
Detailed description
Nearly 1.5 million patients present to US emergency departments (ED) annually following head trauma. Many, even with a low velocity mechanism of injury, report a variety of post-concussion symptoms, including headache, dizziness, and nausea. For most patients, post-concussion symptoms will resolve after several days, though up to 1/4 will develop persistent symptomatology that can last months or years. Very few randomized studies are available to guide treatment of acute post-concussion symptoms. In the absence of evidence, most emergency physicians treat post-concussion symptoms using typical medications for the symptom - thus headache is treated with analgesic medication, nausea with antiemetics, and dizziness with medications such as meclizine. Other symptoms commonly described as part of post-concussion syndrome, such as fatigue, irritability, and poor concentration, are usually left untreated. Two randomized studies among ED patients who experienced head trauma were recently completed at Montefiore EDs. In the first, one dose of IV metoclopramide, when compared to placebo, improved post-concussion syndrome both in the ED and one week later. In this study, IV metoclopramide was effective against a broad range of symptoms beyond just headache and nausea. Variables related to concentration (including concentration, remembering, and feeling like one is in a fog) were better in the metoclopramide arm at both one hour and at one week. Similarly, variables related to emotion (including feeling more emotional, irritability and sadness) were better in the active group. In the second study, adding IV dexamethasone to metoclopramide did not result in increased or prolonged efficacy.
Interventions
Intravenous drip
DRUGAcetaminophen
Intravenous drip over 15 minutes
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Comparative effectiveness study. Randomization will occur in blocks of four based on a random number generator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults presenting to one of the study emergency departments (EDs) * Acute minor traumatic brain injury/concussion as defined by the Zurich Consensus Statement, including symptoms in somatic, cognitive, emotional, behavioral, physical, cognitive impairment, or sleep domains * ED visit occurring within 7 days of the head injury * Overall pain intensity greater than \>=6 on a 0-10 scale * Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10 * Reported post-concussion symptoms were not present prior to the injury * Treating attending physician plans to administer a parenteral medication
Exclusion criteria
* Already treated with an anti-dopaminergic medication for post-concussion symptoms * Contraindications to study medications, including: * Pheochromocytoma * Seizure disorder * Parkinson's disease * Use of monoamine oxidase (MAO) inhibitors * Use of anti-rejection transplant medications * Pregnant patients will not be excluded because both acetaminophen and metoclopramide are commonly used during pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score | From baseline to 48 hours post-treatment | Change in post-concussion symptoms from baseline to 48 hours after treatment will be measured using the RPQ. The RPQ is a validated instrument designed to quantify the severity of post-concussive symptoms following mild traumatic brain injury. It consists of 16 items encompassing physical (e.g., headache, dizziness), cognitive (e.g., poor concentration, forgetfulness), and emotional (e.g., irritability, depression) domains, each rated on a 5-point Likert scale from 0 ("Not experienced at all") to 4 ("A severe problem"), for an overall possible range of 0-64, such that higher scores reflect worsening concussive symptomatology. Absolute change from baseline scores will be summarized by study arm using descriptive statistics. For patients requiring rescue therapy in the ED, the pre-rescue medication RPQ score will be used in lieu of the 48-hour score to ensure that the 48-hour outcome reflects the individual's poor response to the investigational medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in RPQ score Improvement in post-concussion symptoms measured using the RPQ between baseline and 1 hour after treatment. | From baseline to 1 hour and 7 days post-treatment | Change in post-concussion symptoms will also be measured at 1 hour and 7 days post-treatment using the RPQ. The RPQ is a validated instrument designed to quantify the severity of post-concussive symptoms following mild traumatic brain injury. It consists of 16 items encompassing physical (e.g., headache, dizziness), cognitive (e.g., poor concentration, forgetfulness), and emotional (e.g., irritability, depression) domains, each rated on a 5-point Likert scale from 0 ("Not experienced at all") to 4 ("A severe problem"), for an overall possible range of 0-64, such that higher scores reflect worsening concussive symptomatology. For purposes of this study, an absolute change from baseline score will be reported for the 1 hour and 7 days post-treatment timepoints. Values will be summarized by study arm using descriptive statistics. |
Countries
United States
Contacts
CONTACTHamed Sarikhani, MD
CONTACTBenjamin W W.Friedman, MD,MS
PRINCIPAL_INVESTIGATORBenjamin W Friedman, MD,MS
Montefiore Medical Center
Outcome results
None listed