New targeted therapy shows promise for concussion sufferers
NCT ID NCT04549532
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a personalized treatment plan for people with mild traumatic brain injury (concussion) that targets specific symptoms like anxiety, headaches, vision problems, and sleep issues. 169 adults with recent concussions were assigned to either the targeted treatment or usual care. The goal was to see if the tailored approach leads to better symptom relief and brain function recovery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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169 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 49 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants must meet ALL of the following inclusion criteria: * 18-49 years of age * Normal/corrected vision * Diagnosed with complex mTBI in the past 8 days-6 months with clear mechanism of injury * Glascow coma scale (GCS) score no less than 13 * Reported or sign of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness, imbalance, memory problems, vomiting * Complex mTBI-related symptoms and/or impairments in at least one of the following areas: anxiety/mood, cognitive, migraine, ocular, vestibular, sleep, autonomic; per a comprehensive assessment, clinical exam/interview, and adjudication process. Exclusion Criteria: Participants will be excluded if they meet one or more of the following exclusion criteria: * History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral, or bilateral vestibular hypofunction) * History of neurological disorder * Previous moderate to severe TBI * History of brain surgery, malformations or tumors * Diagnosed with cardiac, peripheral or cerebrovascular disease * Experienced chest pain or shortness of breath while at rest or with mild exertion * Been told by a doctor to only conduct physical activity under medical supervision * Previous moderate to severe TBI * \< 8 days or \>6 months following current complex mTBI * Currently pregnant or become pregnant during study * Currently involved in litigation associated with current or previous mTBI * Currently on workman's compensation * Previously participated in the study * Previously received treatment at either site within last two years as this will unblind treatment group(s) * Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups. * Please note that participants with a history of mTBI, ADHD/LD, migraine, or motion sickness will NOT be excluded. We will adjust for any imbalance in the groups on these factors via covariate analysis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Inova Health System - Inova Sports Medicine Concussion Program
Fairfax, Virginia, 22031, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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Other studies related to the condition(s) this trial covers.
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