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OpenTrials
Completed

NCT Number: NCT05432752

Concussion Pen Screening Tool

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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Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

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

  • 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.

Treatment and study plan

Concussion Pen

Device

Device will measure the distance from the eye to the Concussion Pen for ocular motor functions.

Primary outcomes

  1. Concussion Pen versus Current Clinical Evaluation

    Time frame: 1 year

    Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Use of the Concussion Pen in Evaluating Ocular-motor Function in the Concussed and Non-concussed Populations Ages 11 to 18 Years Old.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2022
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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