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Diagnostic Device
I-PAS Goggles for Concussion Diagnosis
N/A
Recruiting
Led By Michael Hoffer, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females from 18-50 years of age who present to the emergency department or urgent/acute care facility at the University of Miami Hospital, Jackson Memorial Hospital, or by direct referral to the clinic with a history of blow or impact to head, period of loss or alteration of consciousness, neurosensory symptoms, and diagnosis of mTBI/Concussion by Emergency Room Staff or Medical Staff
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 months
Awards & highlights
Study Summary
This trial will test whether the IPAS goggle system can accurately diagnose mild traumatic brain injury in people who visit the emergency department or urgent care.
Who is the study for?
This trial is for adults aged 18-50 who've had a head impact and are diagnosed with mild traumatic brain injury (mTBI) or concussion at specific hospitals. It's also for similar adults without head injuries as controls. Excluded are those with severe injuries, past significant head trauma, certain medical conditions, or inability to consent.Check my eligibility
What is being tested?
The study tests the I-PAS Goggle System's ability to diagnose mTBI in community healthcare settings like emergency departments. Researchers want to see if it works reliably outside of traditional hospital environments.See study design
What are the potential side effects?
Since this trial involves diagnostic equipment rather than medication, typical drug side effects aren't expected. However, discomfort or disorientation during use of the goggles could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18-50 years old and was diagnosed with a concussion after a head injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with mTBI
Secondary outcome measures
Time to recover
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Subjects with mTBIExperimental Treatment1 Intervention
Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles.
Group II: Subjects with minor injuriesActive Control1 Intervention
Individuals who come to the emergency department or urgent/acute care facility with minor injuries (such as ankle sprains or knee sprains) will undergo testing with the I-PAS Goggles.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
901 Previous Clinical Trials
409,586 Total Patients Enrolled
NeurolignIndustry Sponsor
7 Previous Clinical Trials
1,642 Total Patients Enrolled
Michael Hoffer, MDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and agree to the study's details on my own.I have had a head injury from something piercing my skull.I am 18-50 years old and was diagnosed with a concussion after a head injury.You have had a head injury where you were unconscious for more than 59 minutes.I have severe difficulty speaking or understanding speech.I have a chronic condition like kidney failure, liver cirrhosis, autoimmune disease, heart or lung disease, or severe arthritis.I have had a head injury that caused bleeding around my brain.I am a child.I am a control participant with minor injuries, not involving the head, and not needing hospital stay.I had a head injury in the last 3 months or had symptoms just before another head injury.You have been diagnosed with mental health disorders like major depression or schizophrenia.I have had issues with my hearing or balance, including past surgeries on my ears.You have been hospitalized for a head injury in the past.You had a head injury with a Glasgow Coma Scale Score of less than 13.I have a diagnosed neurodegenerative condition.You have had a serious head injury from a car accident.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects with mTBI
- Group 2: Subjects with minor injuries
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being enrolled in this investigation?
"The trial is still open for enrollment, as reported on clinicaltrials.gov; the initial posting was made in August of 2018 and has most recently been edited in April of 2022."
Answered by AI
To what extent is the sample population receiving treatment in this research trial?
"Yes, indeed. According to the data hosted on clinicaltrials.gov, this study originally posted on August 1st 2018 is actively searching for 400 volunteers across one research site. The trial was most recently updated on April 20th 2022."
Answered by AI
Does this experiment include elderly participants?
"This clinical trial has a narrow age criterion, being 18-50. However, there are 172 trials available for those younger and 714 studies available to the elderly population."
Answered by AI
Is it possible for me to enroll in this medical experiment?
"This study is recruiting 400 individuals with brain injuries who are between 18 and 50 years old. To be admitted to the trial, these requirements must be met."
Answered by AI
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