CompletedNot Applicable

Targeted Multidomain (T-MD) Interventions for Complex Mild Traumatic Brain Injury (mTBI)

United States169 participantsStarted 2021-06-15

Plain-language summary

Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI.

Who can participate

Age range

18 Years – 49 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focused on 'complex' mild TBI — how would my doctor determine whether my concussion falls into that category, and does that affect which treatments might be right for me?
2The trial measured symptoms using the Neurobehavioral Symptom Inventory and also asked patients to rate their own overall change — what would my current NSI score suggest about where I stand, and would my doctor expect similar interventions to help me?
3Since this trial has already been completed, has my doctor seen or reviewed any published results, and do the findings change their thinking about how to treat my concussion?
4The trial used a 'targeted multidomain' approach, meaning it likely combined several types of treatment at once — is that kind of multi-pronged strategy something my doctor would consider for me, or would they start with a single treatment first?
5The trial used functional near-infrared spectroscopy to measure brain activity — is that kind of brain imaging something that would be useful in tracking my recovery, and is it available through my care team?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neurobehavioral Symptom Inventory (NSI)

Timeframe: NSI will be measured from baseline to 3 months.

Patient Global Impression of Change (PGIC)

Timeframe: The PGIC will be measured from baseline to 3 months.

Functional Near-infrared Spectroscopy (fNIRS)

Timeframe: fNIRS will be conducted two times, once baseline and again at the 4 week visit.

Trial details

NCT IDNCT04549532

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Concussion, Mild trials