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Targeted Multidomain Intervention for Concussion (T-MD Trial)

N/A

Waitlist Available

Led By Anthony P Kontod, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have reported or shown signs of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness, imbalance, memory problems, vomiting

Participants must have been diagnosed with complex mTBI in the past 8 days-6 months with clear mechanism of injury

Must not have

Diagnosed with cardiac, peripheral or cerebrovascular disease

History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral, or bilateral vestibular hypofunction)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the bsi-18 will be measured from baseline to 3 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a targeted multidomain intervention to usual care in military-aged civilians with complex mTBI to see which is more effective.

Who is the study for?

This trial is for military-aged civilians (18-49) who've had a mild traumatic brain injury (mTBI) with symptoms like confusion, dizziness, or memory issues. They must have been diagnosed within the past 8 days to 6 months and have a Glascow coma scale score of at least 13. Exclusions include those with certain vestibular or neurological disorders, severe TBI history, pregnancy, legal actions related to mTBI, or previous participation in this study.

What is being tested?

The study compares targeted multidomain interventions focusing on areas such as anxiety/mood, cognitive functions, migraines etc., against usual behavioral management care. It's designed to see if these specialized treatments are more effective for people with complex mTBI symptoms.

What are the potential side effects?

Since the interventions involve non-pharmacological approaches like behavioral management and targeted therapies for specific symptoms (e.g., cognitive exercises), side effects may be minimal but could include discomfort from engaging in therapeutic activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have experienced symptoms like confusion, dizziness, or memory problems possibly due to a mild brain injury.

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I was diagnosed with a severe concussion between 8 days and 6 months ago.

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My vision is normal or corrected to normal.

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I am between 18 and 49 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with heart, blood vessel, or brain blood flow problems.

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I have a history of balance disorders.

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I have a history of a neurological disorder.

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I have had brain surgery or have brain tumors or malformations.

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I have had chest pain or trouble breathing with little to no activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the bsi-18 will be measured from baseline to 3 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the bsi-18 will be measured from baseline to 3 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the bsi-18 will be measured from baseline to 3 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Near-infrared Spectroscopy (fNIRS)

Neurobehavioral Symptom Inventory (NSI)

Patient Global Impression of Change (PGIC)

Secondary study objectives

Behavioral Symptom Inventory (BSI-18)

Buffalo Concussion Treadmill Test (BCTT)

Clinical Profile Screening Inventory (CP Screen)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: T-MD Intervention GroupExperimental Treatment1 Intervention

Participants will be prescribed 1+ interventions tailored to affected domains.Anxiety/Mood-Cog beh therapy(CBT) for maladaptive beliefs/avoidance/coping behaviors. Graded exposure/activity/relaxation exercises, cognitive restructuring. Cognitive-Accommodations for reduced work/school time/delayed deadlines, more frequent/longer cognitive rest during symptom-provoking activities. Migraine/Headache: Education, relaxation training/mindfulness based therapy. Ocular-Exercises for ocular symptoms, near point convergence, may include Brock string, pencil push-ups, fixation, saccade tracking, pursuits. Sleep-Sleep regulation/hygiene. Mindfulness-based training, morning physical activity, CBT.Vestibular-Exercises for dizziness, visual motion sensitivity, gait, imbalance that may include gaze stability, visual habituation, static and dynamic balance/gait.Autonomic-Graded aerobic exercise. Perform daily aerobic exercise, goal 80% HR max on a stationary bike/treadmill/walking/jogging.

Group II: Behavioral ManagementActive Control1 Intervention

Participants in control group will receive standardized behavioral management strategies including: activity, hydration, nutrition, sleep, and stress management strategies. These strategies provide general methods to manage concussion symptoms and regulate daily activities to assist in the recovery of concussion. Clinicians will discuss and review a behavioral strategies handout with each participant and answer any questions they may have about the information in the handout. Contact time between clinicians and patients will be similar to avoid effects associated with more or less contact time.

0 / 9Eligibility criteria met