Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 6
- 主要终点
- I-PAS Optokinetic Slow Phase Gain Symmetry
研究概览
简要总结
This study will establish the capability of a suite of conventional tests and the Neurolign Dx_100 I-PAS goggle system to reliably and objectively detect mTBI in an acute setting when comparing individuals with mTBI to controls with minor injuries in a similarly stressful environment.
详细描述
The investigators will employ a comprehensive assessment battery to include vestibular/oculomotor, cognitive, and symptom domains using measures that are consistent with the NIH/NINDS common data elements (CDE) and current military clinical practice guidelines (CPG).
Demographic and health history: Subjects will report medical, concussion and health history at your first visit including medications. Subjects may be asked sensitive personal and family history information. Subjects have the right to not disclose the information requested. This medical and concussion history, as well as your date of clearance/recovery from concussion will be abstracted from the medical record for research purposes.
Neurolign Dx_100 I-PAS testing:
I-PAS testing will be conducted by placing the I-PAS goggles on the head of a patient and asking the patient to follow instructions while a set of tests is performed. Each of these tests simply involves eye motions in response to a target. The I-PAS Goggles are FDA approved for the diagnosis of mTBI. Individuals will undergo a subset of tests from the tests listed below.
Tests: Explanation/eye motion Calibration: Adjusting goggles to focus on eyes Gaze horizontal: Looking right and left Predictive saccade: Looking where a subject knows a light will appear Horizontal random Saccade: Looking right and left Vertical random Saccade: Looking up and down Smooth pursuit horizontal: Following an object right and left smoothly Smooth pursuit vertical: Following an object up and down smoothly Memory Guided saccade: Remembering where an object appeared and looking Self-Paced saccade: Self-generated horizontal saccades Anti-saccade: Looking away from an object that appears (opposite direction horizontally, same magnitude) Optokinetic: Following a moving textured background Visual reaction time: Time required to respond with a button press to a visual target Saccade reaction time: Time required to initiate an eye movement to a visual target Auditory reaction time: Time required to indicate with a button press that an auditory stimulus was heard Subjective visual vertical: Aligning a line to be earth-vertical Subjective visual horizontal: Aligning a line to be earth- horizontal Vergence and pupil tests: Binocular disparity step and sinusoidal pursuit tracking by eye and pupil Light Reflex Tests: Consensual pupillary response to light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the mTBI group, participants must present to a recruitment site within 10 days of injury with a diagnosed concussion that meets all of the following criteria:
- •clear mechanism of injury (i.e., direct or indirect impact to head),
- •Glasgow Coma Scale= 13-15, 3) observed or reported signs (e.g., loss of consciousness, amnesia, or confusion) or symptoms (e.g., headache, dizziness, nausea), and
- •neurosensory symptoms.
- •For Control group, participants will have minor, non-surgical injuries (e.g., sprains, strains) not requiring hospital admission and no history of mTBI will be recruited from the same study sites.
排除标准
- •History of moderate to severe TBI characterized by any of the following:
- •Penetrating head trauma
- •GCS< 13 at the time of injury
- •Associated with LOC > 30 minutes or amnesia >24 hours
- •Associated with subdural or epidural hemorrhage
- •mTBI history
- •mTBI Group - history of mTBI within the last 6 months or experiencing head injury symptoms immediately prior to the current head injury or history of 3 or more mTBIs
- •Controls - No history of mTBI within the last 12 months and no presence of any mTBI-related symptoms at time of enrollment
- •Presence of severe aphasia
- •History of diagnosed psychiatric disorder (e.g., schizophrenia)
- •Documented neurological disorders (e.g., Epilepsy, stroke, dementia)
- •Pregnancy (females will be asked if they are pregnant)
- •Prior disorders of hearing and balance including:
- •Meniere's disease
- •Multiple sclerosis
- •Vestibular neuritis
- •Vestibular schwannoma
- •Sudden sensorineural hearing loss
- •History of tumor of the brain or central nervous system
结局指标
主要结局
I-PAS Optokinetic Slow Phase Gain Symmetry
时间窗: 2 min
Comparison of performance in the right and left direction. Range: 0-100%. Lower value is better
Vestibular/Ocular Motor Screening (VOMS) score
时间窗: 5 minutes
Patients verbally rate changes in headache, dizziness, nausea and fogginess symptoms compared to their immediate pre-assessment state on a scale of 0 (none) to 10 (severe) following each of the following tasks: 1) smooth pursuit, 2) horizontal and vertical saccades, 3) convergence, 4) horizontal and vertical vestibular ocular reflex (VOR) and 5) visual motion sensitivity (VMS). A near convergence point is also measured. Lower scores are better on each component.
Immediate Post-concussion Assessment and Cognitive Testing (ImPACT)
时间窗: 25 minutes
ImPACT is a computerized neurocognitive test that includes six modules: 1) verbal memory, 2) design memory, 3) X's and O's, 4) symbol matching, 5) color matching, and 6) three letter memory (ImPACT Applications Inc.). These modules are used to form four composite scores: verbal and visual memory (%), visual motor processing speed (#), and reaction time (RT) (sec). The ImPACT also includes the Post-concussion Symptom Scale (PCSS), which is a 22-item self-reported symptom severity inventory of somatic, cognitive, affective and sleep-related symptoms. Both composite and item scores are used.
Automated Neuropsychological Assessment Measure (ANAM).
时间窗: 20 minutes
ANAM is a computerized neurocognitive test that includes eight test modules: 1) code substitution delayed, 2) code substitution, 3) matching to sample, 4) mathematical processing, 5) procedural reaction time, 6) simple reaction time, 7) simple reaction time repeated, and 8) go/no go (ANAM v. 4.3; Vista Life Sciences). These modules are scored based on accuracy, speed, and throughput (accuracy/mean reaction time). Both composite and item scores are used
Dynamic Visual Acuity Test
时间窗: 5 minutes
First, the lens-corrected static visual acuity will be assessed using a standard Snellen or LogMAR eye chart. The lowest line that all letters can be read will be recorded. For dynamic visual acuity, the patient will flex their head down 30 deg, then rotate their head in the yaw plane at a frequency of about 2 Hz and amplitude of 20-30 deg. A metronome will be used to set the frequency. Again, the lowest line that all letters can be read will be recorded. A loss of greater than 2 lines suggests an impaired vestibulo-ocular reflex.
I-PAS Predictive Saccade Generation Score
时间窗: 2 minutes
First predictive saccade to target in a series. Range:1-24. A lower score is better.
I-PAS Binocular Disparity Vergence Test
时间窗: 3 minutes
Two factor discriminant function classifier for mTBI versus Control subjects
Neurobehavioral Symptom Inventory (NSI)
时间窗: 5 minutes
The NSI is a 22-item (i.e. symptom) scale in which participants rate the severity of symptoms on a 5-point scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe) ranging from 0-60. Both composite and item scores will be analyzed.
I-PAS Antisaccade Task Error Rate
时间窗: 2 minutes
Percent of pro-saccadic errors. Range: 0-100%. A lower score is better.
I-PAS Smooth Pursuit Velocity Gain Symmetry
时间窗: 1 min
Comparison of performance in the right and left direction. Range: 0-100%. Lower value is better.
Modified Balance Error Scoring System (mBESS)
时间窗: 5 minutes
The BESS 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 sec each on a firm surface. All stances are completed with eyes closed and with hands 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.
次要结局
- Dizziness Handicap Inventory (DHI)(5 minutes)
- Behavioral Symptom Inventory-18 (BSI-18)(5 minutes)
- Visual Vertigo Analog Scale (VVAS)(5 minutes)
- Pittsburgh Sleep Quality Index (PSQI)(5 minutes)
研究者
Carey Balaban
Professor
University of Pittsburgh