Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
NCT Number: NCT05432752
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.
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Notify Me11 year–18 year
All sexes
Interventional
Not applicable
Kansas City, Missouri, 64108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for both control and study cohorts, unless stated otherwise below
Exclusion criteria
Device will measure the distance from the eye to the Concussion Pen for ocular motor functions.
Time frame: 1 year
Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation.
Children's Mercy Hospital Kansas City
Other
Use of the Concussion Pen in Evaluating Ocular-motor Function in the Concussed and Non-concussed Populations Ages 11 to 18 Years Old.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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