Principal Investigator: Melissa Cortez
Keywords: TBI , Concussion , Autonomic Nervous System , Head Injury , Headache Department: Neurology
IRB Number: 00125706 Co Investigator: Kevin Brennan
Specialty: Neurology, Neurology, Neurology
Sub Specialties: Traumatic Brain Injury, Migraine, Headache
Recruitment Status: Recruiting

Contact Information

Leah Millsap
leah.millsap@utah.edu
801-581-7978

Simple Summary

This research study is designed to assess whether a series of physiologic tests can distinguish between normal participants and patients who suffered a head injury. This distinction will help guide diagnosis and treatment of head injuries. Physiologic testing includes measurement of a person’s pupil function, heart rate and blood pressure during changes in position and breathing, sensitivity to smells, light (via a test technique called “psychophysics”), facial sensation to touch and temperature, and reaction to smelling salts. Clinical testing includes a neurological exam, history and neuropsychometric tests to fully characterize an individual’s medical history and symptoms. You may have two or more separate visits composed of one or more of the following: 1) clinical assessment and questionnaires; 2) psychophysics (light sensitivity testing); 2) pupil testing; 3) physiology (facial autonomic and blood pressure/heart rate monitoring). In the context of this study, these procedures are considered non-standard, and are not required for your routine medical care. Each participant may consent to all or none, and test schedule can be customized to fit the participant’s scheduling needs, though some of the testing should ideally take place between the hours of 7:30 am and 4 pm. You will be given specific instructions at the start of each task. Please ask the experimenter any questions that may arise during each task.During the clinical assessment visit, you will be asked a series of questions about your medical history and medication use, as well as to fill out a series of medical questionnaires, requiring approximately 20 minutes to complete. For the psychophysics testing, you will be asked to report detection of certain smells (odor sensitivity testing), or a bright light (photophobia testing), each of which will last 15 – 20 minutes.Facial autonomic testing will involve lying still while being photographed with a mounted camera under green lighting. Heart rate, blood pressure and pupil responses are measured during this phase of the study.

Inclusion Criteria

A total of 200 participants, ages 12 years and older will be recruited. Participants will be enrolled into one of the following groups: 

  1. 50 Control: no history of headache or concussion. 
  2. 50 Post-Concussive Syndrome: Per WHO/ICD10 (2007): Participant reports at least three of the following symptoms: headache, dizziness, fatigue, irritability, concentration, memory, insomnia, intolerance to stress and must “persist past the acute post-injury period”. 

 

WHO (World Health Organization).  2010. [October 3, 2013]. (10th Revision. [Online version.]).http://apps​.who.int/classifications​/icd10/browse/2010/en.

 

Ruff RM. Mild traumatic brain injury and neural recovery: Rethinking the debate. 2011;(3):167–80.

 

  1. 50 Acute TBI: Participant with head injury less than 3 months prior, will sub-divide TBI into mild, moderate severe based on below diagnostic criteria. 
    1. Mild: Normal structural imaging, loss of consciousness <30 minutes, alteration of consciousness/mental state lasting seconds to 24 hours, post-traumatic amnesia lasting less than 24 hours, Glasgow Coma Scale 13-15. 
    2. Moderate: Normal or abnormal structural imaging, loss of consciousness lasting 30 minutes to 24 hours, alteration of consciousness/mental state lasting >24 hours, post-traumatic amnesia lasting >1 and <7 days, Glasgow Coma Scale 9-12. 
    3. Severe: Normal to abnormal structural imaging, loss of consciousness lasting >24 hours, alteration of consciousness/mental state lasting >24 hours, post-traumatic amnesia lasting >7 days, Glasgow Coma Scale 3-8. 

 

Brasure M, Lamberty GJ, Sayer NA, et al. Multidisciplinary Postacute Rehabilitation for Moderate to Severe Traumatic Brain Injury in Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jun. (Comparative Effectiveness Reviews, No. 72.) Table 1, Criteria used to classify TBI severity. Available from: https://www.ncbi.nlm.nih.gov/books/NBK98986/table/introduction.t1/

  1. 50 At-risk population: Participants may complete baseline testing if they are deemed by PI to be “at-risk” for TBI. These participants may include recreational sports participants, military personnel, among others. Participants will then be followed for the occurrence of concussion, and complete post-concussion testing as outlined elsewhere in this application.

Exclusion Criteria

Those who cannot provide consent, or where follow up visits would not be feasible. 

Penetrating TBI. 

Patients currently on medications with potential to affect autonomic or sensory testing, in which the medication can’t be held 48 hours prior to testing (e.g. antihypertensives, muscle relaxants, stimulants, and some antidepressants that alter sympathetic function). Participants will be instructed to obtain approval from prescribing providers in cases a medication must be held

Pregnancy. 

Participant Reimbursement

In return for your time and effort, you will be offered monetary compensation at the rate of $10 per hour (not to exceed $100). This includes time spent undergoing clinical assessment and testing modules as described above, but does not include travel or telephone time, and will be rendered in a single sum at the completion of your involvement in the study. Participants are not required to complete all study modules, though will receive compensation only after completing the study visits.