Concussion Pen Screening Tool

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-28

Study Completion Date

2023-01-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fixation, Ocular Brain Concussion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Concussed Subjects

Subjects with known history of concussion will be evaluated using current clinical evaluation and also using the Concussion Pen.

Group Type EXPERIMENTAL

Concussion Pen

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Concussion Pen

Intervention Type DEVICE

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

Interventions

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Concussion Pen

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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.

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No