Brain Concussion, Fixation, Ocular
Conditions
Keywords
Ocular motor function, Concussion
Brief summary
To compare the use of the Concussion Pen to current clinical care practice. This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized. This randomization will help to control for evaluation fatigue on the part of study participants.
Detailed description
This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized. This will be a multi-disciplinary team with members of Physical Therapy (PT)/ Occupational Therapy (OT), Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), and Doctor of Philosophy(PhD)s who specialize in concussion assessment. This study will include a population of concussed patients as well as non-concussed patients (controls) who will be seen in CM clinics per standard of care.
Interventions
DEVICEConcussion Pen
Device will measure the distance from the eye to the Concussion Pen for ocular motor functions.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for both control and study cohorts, unless stated otherwise below * Patients cognitively 11 to 18 years of age. * Patients undergoing evaluation for concussion in Children's Mercy (CM) clinics for concussion population. * Patients with a history of concussion at any previous point in time (no time limits to this date). * Patients with no history of concussion and being seen at CM PT/OT for other diagnoses for control population. * Patients able to give verbal assent or consent (dependent on patient cognitive age), and Legally Authorized Representatives (LAR)s able to give verbal parental permission. * English-speaking families.
Exclusion criteria
* Patients not within the inclusion criteria as outlined above. * Patients with congenital vestibular dysfunction will not be included. * Patients diagnosed with dyslexia or Attention Deficit Hyperactive Disorder (ADHD) will not be included. * Non-English-speaking families. * Wards of the State will not be approached for this study. * Patients with a previous diagnosis of strabismus or convergence insufficiency will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concussion Pen versus Current Clinical Evaluation | 1 year | Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation. |
Countries
United States
Outcome results
None listed