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New targeted therapy shows promise for concussion sufferers

NCT ID NCT04549532

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

169 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2025

Lead sponsor

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

18 to 49 years

Sex

Anyone

Healthy volunteers

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

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.

Brain Concussion traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Inova Health System - Inova Sports Medicine Concussion Program

    Fairfax, Virginia, 22031, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

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