Concussion Pen for Fixation, Ocular

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Mercy Hospital, Kansas City, MO
Fixation, Ocular+1 More
Concussion Pen - Device
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Fixation, Ocular
  • Brain Concussion

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
Concussion Pen versus Current Clinical Evaluation

Trial Safety

Trial Design

2 Treatment Groups

Non-Concussed Subjects
1 of 2
Concussed Subjects
1 of 2
Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Concussion Pen · No Placebo Group · N/A

Non-Concussed Subjects
Device
Experimental Group · 1 Intervention: Concussion Pen · Intervention Types: Device
Concussed Subjects
Device
Experimental Group · 1 Intervention: Concussion Pen · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: Children's Mercy Hospital · Kansas City, MO
Photo of kansas city 1Photo of kansas city 2Photo of kansas city 3
2011First Recorded Clinical Trial
1 TrialsResearching Fixation, Ocular
250 CompletedClinical Trials

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
223 Previous Clinical Trials
1,268,852 Total Patients Enrolled
Andrea Thorne, PTPrincipal InvestigatorChildren's Mercy Hospital Kansas City

Eligibility Criteria

Age < 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to give verbal consent or consent, and a LAR is able to give verbal parental permission.
The study cohort was included in the control cohort.
Patients undergoing evaluation for concussion in Children's Mercy (CM) clinics for concussion population.
You have no history of concussion and you are seen at CM PT/OT for other diagnoses.
You have a history of a concussion at any previous point in time.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.