Traumatic brain injury (TBI) ranges from mild concussion to severe brain damage and is a leading cause of disability and death in young adults. Despite decades of research, no drug has proven effective in severe TBI — making this one of the most persistent unmet needs in neurology.
What's actually going on in research
Progesterone, tranexamic acid, and a variety of neuroprotective agents have been tested in large TBI trials without success, leading researchers to rethink trial design and patient selection using biomarkers like GFAP and UCH-L1. Emerging approaches include stem cell therapies, exosomes, and drugs targeting secondary injury cascades such as neuroinflammation and excitotoxicity. For chronic TBI, amantadine and other neurostimulants improve some cognitive outcomes, and non-invasive brain stimulation approaches are in trials for post-TBI depression and cognitive dysfunction.
Neuroprotective drugs
New drugs targeting glutamate excitotoxicity, neuroinflammation, and mitochondrial failure in the hours to days after brain injury are in early and mid-stage trials.
Stem cell and exosome therapy
Mesenchymal stem cells and the tiny vesicles they release (exosomes) are being tested in moderate-to-severe TBI for their potential to reduce inflammation and support brain repair.
Neuromodulation for recovery
Transcranial magnetic stimulation, transcranial direct current stimulation, and vagus nerve stimulation are in trials for post-TBI cognitive impairment and mood disorders.
What to know before you search
Eligibility depends on TBI severity classification, time since injury, age, neuroimaging findings, and Glasgow Coma Scale score for acute trials.
What types of trials are currently open
- Acute treatment trials — Testing neuroprotective drugs, surgical approaches, and monitoring strategies in the first days after severe TBI.
- Rehabilitation trials — Comparing intensive rehabilitation, cognitive training, and technology-assisted therapy for chronic TBI deficits.
- Neuromodulation trials — Testing brain stimulation devices for cognitive, mood, and motor recovery after TBI.
- Drug trials — Evaluating pharmacological support for attention, memory, depression, and spasticity in TBI survivors.
- Observational studies — Using biomarkers and imaging to understand TBI progression and predict long-term outcomes.
Recently added Traumatic Brain Injury trials
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)
The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention. Participants will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from the Pediatric Emergency Department. A weekly phone meeting will be performed with all participants to assess recovery progress. Participants randomized to the intervention group will also be asked about their exercises, will be provided specific instructions and adjustments as necessary. All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment, information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.
Recovery Among Older Adults Following Mild TBI
Among fall related injuries in older adults, head injuries are the most common, yet almost nothing is known about recovery from head injury, also known as traumatic brain injury or TBI, in this population. The RETRO-TBI study is a prospective cohort study of 250 adults aged 65 and older with mild TBI to evaluate recovery in cognitive, physical and psychological function and sleep quality at four timepoints (2 weeks and 3, 6, and 12 months) over the year following injury and identify factors associated with recovery trajectories. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform future development of strategies to optimize recovery following this common fall-related injury among older adults.
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