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Diagnostic Test

Diagnostic test for Traumatic Brain Injury

N/A

Recruiting

Led By Carey D Balaban, PhD

Research Sponsored by Carey Balaban

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

mTBI group: Participants must present to a recruitment site within 10 days of injury with a diagnosed concussion that meets specific criteria including clear mechanism of injury, Glasgow Coma Scale= 13-15, observed or reported signs or symptoms, and neurosensory symptoms

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 minutes

Awards & highlights

Study Summary

This trial will test how well a set of common tests and a new brain injury detection system can identify people with mild brain injuries compared to those with only minor injuries.

Who is the study for?

This trial is for individuals who have recently experienced a mild traumatic brain injury (mTBI), such as a concussion, and are within 10 days of the incident. They must show specific symptoms but be relatively stable (Glasgow Coma Scale=13-15). A control group with minor injuries but no mTBI will also participate. Excluded are those with severe speech issues, certain psychiatric or neurological disorders, pregnant women, significant past head trauma, or hearing and balance disorders.Check my eligibility

What is being tested?

The study tests how well traditional assessments and the Neurolign Dx_100 I-PAS goggle system can identify mTBI in an emergency setting by comparing results from injured participants to those without brain injuries.See study design

What are the potential side effects?

Since this trial involves diagnostic tests rather than medications or invasive treatments, side effects are minimal. Participants may experience discomfort or dizziness during testing with the I-PAS goggles due to their design to assess balance and eye movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a concussion within the last 10 days with specific symptoms and a clear injury cause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Automated Neuropsychological Assessment Measure (ANAM).

Dynamic Visual Acuity Test

I-PAS Antisaccade Task Error Rate

+8 more

Secondary outcome measures

Behavioral Symptom Inventory-18 (BSI-18)

Dizziness Handicap Inventory (DHI)

Pittsburgh Sleep Quality Index (PSQI)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mild Traumatic Brain Injury ParticipantsExperimental Treatment1 Intervention

Males and females from 18-50 years of age who present to a recruitment site within 10 days of injury with a diagnosed concussion that meets all of the following criteria: 1) clear mechanism of injury (i.e., direct or indirect impact to head), 2) Glasgow Coma Scale= 13-15, 3) observed or reported signs (e.g., loss of consciousness, amnesia, or confusion) or symptoms (e.g., headache, dizziness, nausea), and 3) neurosensory symptoms.

Group II: Control ParticipantsActive Control1 Intervention

Age- and sex-matched control subjects with minor, non-surgical injuries (e.g., sprains, strains) not requiring hospital admission and no history of mild traumatic brain injury will be recruited from the same study sites.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diagnostic test

2018

N/A

~4190

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carey BalabanLead Sponsor

Uniformed Services University of the Health SciencesFED

116 Previous Clinical Trials

91,118 Total Patients Enrolled

University of MiamiOTHER

902 Previous Clinical Trials

409,566 Total Patients Enrolled

Media Library

Standardized Instruments and Neurolign Dx_100 I-PAS goggle system (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04372797 — N/A

Concussion Research Study Groups: Control Participants, Mild Traumatic Brain Injury Participants

Concussion Clinical Trial 2023: Standardized Instruments and Neurolign Dx_100 I-PAS goggle system Highlights & Side Effects. Trial Name: NCT04372797 — N/A

Standardized Instruments and Neurolign Dx_100 I-PAS goggle system (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04372797 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants in this trial restricted to those under the age of thirty?

"For this medical investigation, only those aged between 18 and 50 are eligible for enrollment. By contrast, 169 trials will accept minors while 708 clinical studies welcome senior citizens."

Answered by AI

How many individuals have signed up for this trial thus far?

"To adequately complete this medical study, 450 eligible subjects are required. From Naval Medical Center San Diego in California to University of Pittsburgh in Pennsylvania, many locations offer participation opportunities for qualified volunteers."

Answered by AI

Are there any openings remaining for participants in this medical experiment?

"Data hosted on clinicaltrials.gov reveals that this research project, which was initially posted on September 30th 2020, is presently enlisting participants. The trial has seen its most recent update as of November 2nd 2022."

Answered by AI

What aims does this research endeavor seek to accomplish?

"This 25-minute clinical trial is aimed to evaluate patients' performance on the Automated Neuropsychological Assessment Measure (ANAM). Secondary objectives include an analysis of psychological distress via the Behavioral Symptom Inventory-18, handicap level associated with dizziness through a Dizziness Handicap Inventory assessment and Vertigo Analog Scale."

Answered by AI

Who meets the prerequisites for taking part in this research?

"This medical experiment is looking to enrol 450 individuals aged 18-50 with wounds. To be considered for the Control group, prospective participants must have minor traumas (e.g. sprains and strains) that do not need hospital admission, a Glasgow Coma Scale of 13-15, evidence of signs or symptoms such as loss of consciousness, amnesia and confusion or neurosensory manifestations like headaches, dizziness and nausea respectively."

Answered by AI

Recent research and studies

NeurosurgeryJournal

Statements of Agreement from the Targeted Evaluation and Active Management (TEAM) Approaches to Treating Concussion Meeting Held in Pittsburgh, October 15-16, 2015

Collins, Michael W., Anthony P. Kontos, David O. Okonkwo, Jon Almquist, Julian Bailes, Mark Barisa, Jeffrey Bazarian, et al.. 2016. “Statements of Agreement from the Targeted Evaluation and Active Management (TEAM) Approaches to Treating Concussion Meeting Held in Pittsburgh, October 15-16, 2015”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/neu.0000000000001447.

Laryngoscope Investigative OtolaryngologyJournal

The Use of Oculomotor, Vestibular, and Reaction Time Tests to Assess Mild Traumatic Brain Injury (mtbi) over Time

Hoffer, Michael E., Carey Balaban, Mikhaylo Szczupak, James Buskirk, Hillary Snapp, James Crawford, Sean Wise, et al.. 2017. “The Use of Oculomotor, Vestibular, and Reaction Time Tests to Assess Mild Traumatic Brain Injury (mtbi) over Time”. Laryngoscope Investigative Otolaryngology. Wiley. doi:10.1002/lio2.74.

Plos OneJournal

Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury

Balaban, Carey, Michael E. Hoffer, Mikhaylo Szczupak, Hillary Snapp, James Crawford, Sara Murphy, Kathryn Marshall, Constanza Pelusso, Sean Knowles, and Alex Kiderman. 2016. “Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury”. Edited by Damir Janigro. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0162168.

The American Journal of Sports MedicineJournal