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New combo therapy aims to quiet dizziness and worry after concussion

NCT ID NCT06819904

Symptom relief Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This study tests a new treatment called ACTIVE that combines counseling (Acceptance and Commitment Therapy) with balance exercises for people with mild traumatic brain injury. Researchers want to see if it helps reduce dizziness and anxiety better than standard balance therapy alone. The trial will enroll 250 adults aged 18-49 and track their progress for 6 months after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acceptance and Commitment Therapy combined with vestibular rehabilitation (behavioral therapy and balance exercises)
What this could lead to
If it works, this could offer a more effective way to reduce dizziness and anxiety after mild concussion, improving daily life for many.
What could go wrong
This is a mid-stage trial with 250 people, so results may not apply to everyone. The therapy requires active participation and may not work for all types of concussion symptoms.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

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: * 18-49 years of age * Normal/corrected vision * Diagnosed with mTBI per military clinical practice guidelines (CPGs) that occurred over 8 days prior to consent as determined by a multi-domain assessment performed by a licensed healthcare professional. * mTBI-related symptoms and/or impairments in at least one or more areas, including vestibular (dizziness, imbalance), psychological health (anxiety, depression, stress), cognitive (memory problems), headache/migraine, ocular, or sleep. as determined by self-report. Exclusion Criteria: * History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report. * History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report. * Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report. * Previous moderate to severe TBI as determined by self-report. * \< 8 days following current mTBI as determined by self-report. * Currently pregnant as determined by self-report.

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Conditions

The condition(s) this trial relates to.

Brain Concussion Psychological Well-Being traumatic brain injury vestibular disorder

As listed by the trial registrant

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

Concussion, mild Mild traumatic brain injury (MTBI) Psychological health Vestibular

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Intrepid Spirit Center, Carl R. Darnall Army Medical Center

    NOT_YET_RECRUITING

    Fort Hood, Texas, 76544, United States

  • University of Pittsburgh Concussion Research Laboratory

    RECRUITING

    Pittsburgh, Pennsylvania, 15213-4512, United States

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