Concussion Pen Screening Tool

Brain Concussion Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432752
• Other study ID #: STUDY00002250
• Status: Completed
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: January 25, 2023

Study information

• Verified date: February 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion

Intervention

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

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concussion Pen versus Current Clinical Evaluation	Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation.	1 year