Montefiore Medical Center
New York, 10467, United States
Location contact
Benjamin W.Friedman, MD,MS
CONTACT
Hamed Sarikhani Assistant Professor of Emergency Medicine, MD
CONTACT
NCT Number: NCT07634393
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
New York, 10467, United States
Benjamin W.Friedman, MD,MS
CONTACT
Hamed Sarikhani Assistant Professor of Emergency Medicine, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous drip
Intravenous drip over 15 minutes
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 7 days post-treatment
Change in pain score from baseline to 7 days post-treatment will be assessed using the NRS for pain. The NRS is a commonly used rating scale for pain in ED studies and is comprised of a segmented, 11-point assessment wherein patients verbally identify their pain severity on a scale ranging from 0 ("No pain") to 10 ("Worst pain imaginable"), such that higher scores are indicative of increased pain intensity. For purposes of this outcome, a relative change from baseline score will be reported for the 7-day post-treatment timepoint. Values will be summarized by study arm using descriptive statistics. Changes in pain scores will be analyzed in relation to RPQ symptom improvement as an exploratory outcome.
Contact information is provided by the study sponsor or research team.
Benjamin W W.Friedman, MD,MS
CONTACT
Hamed Sarikhani, MD
CONTACT
Montefiore Medical Center
Other
A Randomized Study of Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment
Acronym: IMPACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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