Targeted Multidomain (T-MD) Interventions for Complex Mild Traumatic Brain Injury (mTBI) (T-MD)
Concussion, Mild
About this trial
This is an interventional treatment trial for Concussion, Mild focused on measuring concussion, mTBI
Eligibility Criteria
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.
Sites / Locations
- University of PittsburghRecruiting
- Inova Health System - Inova Sports Medicine Concussion ProgramRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
T-MD Intervention Group
Behavioral Management
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.
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.