Status:
UNKNOWN
Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD: Neurokinetics, Inc, iPAS
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
The Citadel, The Military College of North Carolina
Conditions:
Traumatic Brain Injury
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-55 years
Brief Summary
The long term goal for the Traumatic Injury Research Program (TIRP) is testing of novel devices for the identification and longitudinal assessment of traumatic brain injury (TBI). DoD (United States D...
Detailed Description
Traumatic brain injury is not only a significant medical and operational issue for the military but is a significant public health issue in the United States. The CDC reports that 1.4 million American...
Eligibility Criteria
Inclusion
- Male and female participants
- Between 18 and 55 years old
- In good general health. Good general health is operationalized for the purpose of this study by scores within one standard deviation of the mean in all eight sections of the short form 36.
- A normalized Global Severity Scale of less than or equal to 65 on the Symptom Checklist 90-R and subscale scores less than the cut scores indicating significant pathology.
Exclusion
- Traumatic brain injury positive as determined by the DVBIC 3 Question Screening Tool.
- Any history of seizures or Central Nervous System (CNS) tumors
- A normalized Global Severity Scale of more than 65 on the Symptom Checklist 90-R or any subscale score indicating significant pathology.
- Scores greater than one standard deviation from the mean on all eight sections of the Short Form 36.
Key Trial Info
Start Date :
February 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03465995
Start Date
February 22 2018
End Date
September 30 2020
Last Update
February 13 2020
Active Locations (1)
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1
The Citadel
Charleston, South Carolina, United States, 29409