Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Neurobehavioral Symptom Inventory (NSI) |
NSI is a 22 item symptom scale, participants will rate the severity of their symptoms on a 5 point likert scale (0, none/rarely ever present to 4, very severe, almost always present). The NSI total score is a sum of the 22 items (range 0-88). |
NSI will be measured from baseline to 3 months. |
|
| Primary |
Patient Global Impression of Change (PGIC) |
PGIC is a self-reported assessment of change. Participants rate their impression of how much better they feel on a 7 point likert scale. It is a 1 item survey, with higher scores representing no change and associated with feeling worse. (Responses 1=much improved, 2=minimally improved, 3=no change, 4=minimally worse, 5=much worse, 6=very much worse). |
The PGIC will be measured from baseline to 3 months. |
|
| Primary |
Functional Near-infrared Spectroscopy (fNIRS) |
fNIRS will be used to record changes in oxygenated hemoglobin (activation) and deoxygenated hemoglobin (deactivation) in participants. fNIRS will assess 3 broad regions of interest: left and right temporal, occipital. It will measure bilateral areas of the inferior frontal, dorsal-lateral prefrontal, and frontal regions of the brain including Brodmann areas as well as the middle frontal gyrus, superior temporal gyrus, and extrastriate visual cortical regions. fNIRS will be done in 2 different paradigms: 1) at rest, and 2) during cognitive activity. At rest measurements will occur while participants are seated, and last about 2 minutes. For the cognitive activity, participants will perform the ImPACT test while wearing the fNIRS unit, and last 20 minutes. We will compare brain activation and deactivation in ROIs across the two points and between rest and cognitive activity paradigms. We will also examine task specific changes within the cognitive test paradigm. |
fNIRS will be conducted two times, once baseline and again at the 4 week visit. |
|
| Secondary |
Behavioral Symptom Inventory (BSI-18) |
The BSI is an 18 item symptom inventory that assesses the level of psychological distress during the past 7 days. Responses are on a 5 point Likert scale (0=not at all - 4 = extremely). The BSI-18 yields total global severity index ranging from 0-72, as well as somatic, depression and anxiety sub-scales. Higher scores indicate higher levels of psychological distress. |
The BSI-18 will be measured from baseline to 3 months. |
|
| Secondary |
Dizziness Handicap Inventory (DHI) |
The DHI is a 25 item self-reported measure that examines dizziness-related handicap. The assessment has 3 domains (functional, emotional, and physical). Participants self-report the level dizziness has impacted their abilities in the 3 domains with each domain having 9 questions (questions are answered No (0)/Sometimes(2)/Yes(4)) Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional). Minimum score is 0. |
The DHI will be measured from baseline to 3 months. |
|
| Secondary |
Vestibular Ocular Motor Screening (VOMS) |
The VOMS assesses impairment via patient report symptom provocation following each of 5 test components (smooth pursuits, horizontal/vertical saccades, convergence, horizontal and vertical vestibular ocular reflex (VOR) and visual motor sensitivity (VMS). Patients verbally rate changes in headache, dizziness, nausea, and fogginess after each test, as well as report their baseline symptoms. Symptoms in each area are rated on scale 0 (none) to 10 (severe). Scores on any VOMS item of 2+ reflects a positive screening cut-off for vestibular and/or ocular motor impairment. |
VOMS will be will be measured from baseline to 4 weeks. |
|
| Secondary |
Modified Balance Error Scoring System (mBESS) |
The mBESS measures postural stability and consists of three stances including feet side by side, a tandem stance, and a single-leg stance on the non-dominant leg. The three stances are performed for 20 seconds each and completed with eyes closed and hand on the iliac crests. Errors include lifting hands off the iliac crests, opening the eyes, stepping, stumbling, or falling, moving the hip into more than a 30 degree of flexion or abduction, lifting the forefoot or heel, or remaining out of the testing position for more than 5 seconds. Each error equals 1 point, with higher scores indicating worse performance. Score ranges from 0-30 (maximum of 10 errors per each stance). |
mBESS will be measured from baseline to 4 weeks. |
|
| Secondary |
Functional Gait Assessment (FGA) |
FGA is 10 items that assesses the ability of participants to walk with head turns, changes of speed of walking, and walking around obstacles. Each item is scored on a 4 point ordinal scale; 0 (severe impairment), 1 (moderate impairment), 2 (mild impairment), 3 (normal ambulation). Score range is 0-30. |
The FGA will be measured from baseline to 4 weeks. |
|
| Secondary |
Clinical Profile Screening Inventory (CP Screen) |
The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87. |
The CP screen will be measured from baseline to 3 months. |
|
| Secondary |
Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) |
ImPACT will be used to assess neurocognitive performance. ImPACT is a computerized neurocognitive test that includes 6 modules: 1) verbal memory, 2) design memory, 3) X's and O's, 4) symbol matching, 5) color matching, and 6) three letter memory. These modules are used to form/score four composite scores - verbal and visual memory 5), visual motor processing speed 6), and reaction time (seconds). |
ImPACT will be administered at baseline, 2 week, 4 week visits. |
|
| Secondary |
Pittsburgh Sleep Quality Index (PSQI) |
The PSQI assesses sleep quality. It is an 19 item self-reported measure that is comprised of seven component scores: 1) subjective sleep quality, 2) sleep latency, 3) sleep duration, 4) sleep efficiency, 5) sleep disturbances, 6) sleep medication usage, and 7) daytime dysfunction. Each item is scored 0-3 (0 = very good, 1 = fairly good, 2= fairly bad, 3=very bad). Higher scores indicate more sleep dysfunction. Score range is 0-21. |
The PSQI will be measured from baseline to 3 months. |
|
| Secondary |
Headache Impact Test (HIT-6) |
The HIT-6 is comprised of 6 self-report items that assess frequency, severity and limitations of daily activities, fatigue, irritability, and concentration related to headaches. Items score from 6 to 13, with higher scores indicating worse severity. Scores = never = 6pts, rarely = 8 pts, sometimes = 10pts, very often = 11 pts, always = 13 points. Score range 36-78. |
The HIT-6 will be measured from baseline to 3 months. |
|
| Secondary |
ID Migraine |
The ID Migraine will be used to screen for headache symptoms. It is a 3 item screening tool designed to assess presence (yes/no) of symptoms related to headache/migraine pain. Scores range from 0-3 with clinical cut-off of 2+ indicating presence of migraines. |
ID Migraine will be measured from baseline to 3 months. |
|
| Secondary |
Short Form McGill Pain Questionnaire (SF-MPQ) |
The SF-MPQ is a 15 item pain scale in which participants rate the intensity of their pain on a 4 point likert scale 0 (none) to 3 (severe). The assessment has two subscales (sensory and affective). Higher scores indicate higher pain. Score range 0-75. |
The SF-MPQ will be measured from baseline to 3 months. |
|
| Secondary |
International Physical Activity Questionnaire (IPAQ) |
The International Physical Activity Questionnaire (IPAQ) will be used to assess potential treatment group differences in activity level. The IPAQ is a validated tool to assess recall of average activity level and intensity over the preceding 7 days. Activity levels can be expressed as categorical variables (low, medium, high activity levels) or a continuous variable (MET-minutes/week). |
The IPAQ will be measured from baseline to 3 months. |
|
| Secondary |
Buffalo Concussion Treadmill Test (BCTT) |
The BCTT will be used in this study to measure autonomic dysfunction of participants' following mTBI. Prior to test initiation, resting heart rate (HR) is measured after a 2 minute seated resting period. A visual analog scale is used to rate symptoms at baseline. |
The BCTT will be completed at 2 study timepoints (baseline and 4 weeks). |
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