Status:

COMPLETED

Concussion Pen Screening Tool

Lead Sponsor:

Children's Mercy Hospital Kansas City

Conditions:

Fixation, Ocular

Brain Concussion

Eligibility:

All Genders

11-18 years

Phase:

NA

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...

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 e...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 28 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 25 2023

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT05432752

Start Date

July 28 2022

End Date

January 25 2023

Last Update

March 2 2023

Active Locations (1)

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1

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108