Concussion Pen Screening Tool

NCT05432752 | Completed

• 1 other identifier: STUDY00002250
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Fixation, Ocular; Brain Concussion

Keywords

Ocular motor function; Concussion

Outcome Measures

Primary Outcomes (1)

• Concussion Pen versus Current Clinical Evaluation

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

  1 year

Study Arms (2)

Concussed Subjects

EXPERIMENTAL

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

Device: Concussion Pen

Non-Concussed Subjects

EXPERIMENTAL

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

Interventions

Concussion Pen DEVICE

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

Concussed Subjects; Non-Concussed Subjects

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Andrea Thorne, PT

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: July 28, 2022
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)