It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.
Today, we're taking a look at five clinical trials with upcoming completion dates (all set to complete by the end of 2028) focusing on concussion and post-concussion symptoms. Trials are arranged by start date.
Quick View Table of Concussion Clinical Trials
| Study Title | Phase | Recruiting? | Enrollment | Start Date | Estimated Primary Completion |
|---|---|---|---|---|---|
| Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment (IMPACT) | 4 | Not yet | 200 (estimated) | August 2026 | June 2028 |
| Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion | 2,3 | Not yet | 35 (estimated) | June 2026 | June 2028 |
| Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy | 2 | Yes | 54 (estimated) | October 2025 | September 2026 |
| BCAAs in Concussion 2.0 | 2 | No | 17 | April 2025 | August 2026 |
| Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI) | 3 | Yes | 146 (estimated) | July 2024 | June 2028 |
Featured Clinical Trials
Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment (IMPACT)
- Sponsor: Montefiore Medical Center
- Goal: 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.
- Interventions: Metoclopramide 10mg, acetaminophen
- Primary Outcome Measure: Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score.
- Time Frame: From baseline to 48 hours post-treatment.
- Study Details
- Source
Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion
- Sponsor: University of Florida
- Goal: The objective of this application is to treat female athletes with depression and concussion with the Optimized, Neuroplasticity-Enhanced techniques in Depression (ONE-D) protocol. This is an innovative, one-day duration TMS treatment for depression.
- Interventions: ONE-D TMS protocol and d-cycloserine (125 mg)
- Primary Outcome Measures: Patient Health Questionnaire 9 (PHQ-9) depression symptom inventory scores; Sport Mental Health Assessment Tool 1 (SMHAT-1) depression symptom inventory scores.
- Time Frames: Baseline, 12 weeks; Baseline, six weeks, 12 weeks.
- Study Details
- Source
Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)
- Sponsor: Foundation for Advancing Veterans’ Health Research
- Goal: A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD).
- Interventions: Quetiapine Fumarate, TAU
- Primary Outcome Measures: Neurobehavioral Symptom Inventory; World Health Organization Disability Assessment Scale; World Health Organization Quality of Life BREF.
- Time Frames: Two weeks; 30 days; Two weeks.
- Study Details
- Source
Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy
- Sponsor: Summit Hyperbarics and Wellness
- Goal: The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans.
- Interventions: Hyperbaric oxygen therapy
- Primary Outcome Measures: PTSD Checklist for DSM-5 (PCL-5); NeuroTrax; Patient Health Quastionnaire-9 (PHQ-9); Generalized Anxiety Disorder 7-item scale (GAD-7); World Health Organization Quality of Life (WHOQOL-BREF)
- Time Frames: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session; From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session; From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session; From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.
- Study Details
- Source
BCAAs in Concussion 2.0
- Sponsor: Akiva Cohen
- Goal: This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery.
- Interventions: BCAA, placebo
- Primary Outcome Measure: Number of participants that have met criteria for recovery at 28 days post-injury, defined as return to baseline symptom levels along with feeling > 90% back to normal.
- Time Frame: 28 days.
- Study Details
- Source
Related Guidelines:
- Management of Concussion-Mild Traumatic Brain Injury
- Veterans Health Administration / Department of Defense (VA/DoD)
- January 2021
- Concussion in Sport
- American Medical Society for Sports Medicine (AMSSM)
- January 2019
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