Clinical trial NCT05432752: Concussion Pen Screening Tool
Official title: Use of the Concussion Pen in Evaluating Ocular-motor Function in the Concussed and Non-concussed Populations Ages 11 to 18 Years Old.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fixation, Ocular
Brain Concussion
Keywords: Ocular motor function
Concussion
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 21
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concussion Pen versus Current Clinical Evaluation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Andrea Thorne, PT
role: PRINCIPAL_INVESTIGATOR
References: