Concussion Pen Screening Tool

Not Applicable

Completed

• Conditions: Fixation, Ocular; Brain Concussion
• Interventions: Device: Concussion Pen

• Registration Number: NCT05432752
• Lead Sponsor: Children's Mercy Hospital Kansas City

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.

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-27
• Study Start: 2022-07-28
• Primary Completion: 2023-01-25
• Study Completion: 2023-01-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Concussed Subjects	Concussion Pen	Subjects with known history of concussion will be evaluated using current clinical evaluation and also using the Concussion Pen.
Non-Concussed Subjects	Concussion Pen	Subjects with no known history of concussion will be evaluated using current clinical evaluation for a concussion and also using the Concussion Pen.

Primary Outcome Measures

Name	Time	Method
Concussion Pen versus Current Clinical Evaluation	1 year	Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation.

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States