Concussion Pen Screening Tool

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Concussion; Fixation, Ocular
• Intervention / Treatment: Device: Concussion Pen

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Thorne, PT; Phone Number: 51652 816-234-3380; Email: ajthorne@cmh.edu
• Study Contact Backup: Name: Jennifer Marshall, MPH, RN; Phone Number: 913-244-9566; Email: jamarshall@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concussed Subjects; Subjects with known history of concussion will be evaluated using current clinical evaluation and also using the Concussion Pen.	Device: Concussion Pen; Device will measure the distance from the eye to the Concussion Pen for ocular motor functions.
Experimental: Non-Concussed Subjects; Subjects with no known history of concussion will be evaluated using current clinical evaluation for a concussion and also using the Concussion Pen.	Device: Concussion Pen; Device will measure the distance from the eye to the Concussion Pen for ocular motor functions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concussion Pen versus Current Clinical Evaluation	Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation.	1 year

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Andrea Thorne, PT, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Concussion; Ocular motor function
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: STUDY00002250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No