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Concussion Pen Screening Tool

Primary Purpose

Fixation, Ocular, Brain Concussion

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Concussion Pen

About this trial

This is an interventional diagnostic trial for Fixation, Ocular focused on measuring Ocular motor function, Concussion

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Concussed Subjects

Non-Concussed Subjects

Arm Description

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

Outcomes

Primary Outcome Measures

Concussion Pen versus Current Clinical Evaluation

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05432752

First Posted

June 21, 2022

Last Updated

February 28, 2023

Sponsor

Children's Mercy Hospital Kansas City

1. Study Identification

Unique Protocol Identification Number

NCT05432752

Brief Title

Concussion Pen Screening Tool

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

July 28, 2022 (Actual)

Primary Completion Date

January 25, 2023 (Actual)

Study Completion Date

January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Mercy Hospital Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fixation, Ocular, Brain Concussion

Keywords

Ocular motor function, Concussion

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Concussed Subjects

Arm Type

Experimental

Arm Description

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

Arm Title

Non-Concussed Subjects

Arm Type

Experimental

Arm Description

Subjects with no known history of concussion will be evaluated using current clinical evaluation for a concussion and also using the Concussion Pen.

Intervention Type

Device

Intervention Name(s)

Concussion Pen

Intervention Description

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

Primary Outcome Measure Information:

Title

Concussion Pen versus Current Clinical Evaluation

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Thorne, PT

Organizational Affiliation

Children's Mercy Hospital Kansas City

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Mercy Hospital

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Concussion Pen Screening Tool

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