Concussion Clinical Trial
Official title:
Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment
This study will synthesize a behavioral profile of impaired driving performance for teenage patients with mild traumatic brain injury (mTBI), or concussion, from one week post-concussion to six weeks post-concussion. It will also elucidate the relation between decreased reaction times exhibited by these patients and their functional response to driving hazards. While a few studies have examined driving performance in adult patients with mTBI, to the investigators knowledge this will be the first investigation of driving performance for teenage patients with mTBI. Therefore, it will provide the foundation for the future development of return-to-drive protocols for physicians and clinical practitioners. This study will synthesize a behavioral profile of impaired driving performance for teenage patients with mild traumatic brain injury (mTBI), or concussion, from one week post-concussion to six weeks post-concussion. It will also elucidate the relation between decreased reaction times exhibited by these patients and their functional response to driving hazards. While a few studies have examined driving performance in adult patients with mTBI, to the investigators knowledge this will be the first investigation of driving performance for teenage patients with mTBI. Therefore, it will provide the foundation for the future development of return-to-drive protocols for physicians and clinical practitioners.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years to 19 Years |
Eligibility |
Inclusion Criteria: - Patients will be defined as those who have suffered closed head trauma diagnosed as mTBI or concussion by one of our network's board-certified sports medicine physicians and based on criteria outlined in recent multi-investigator consensus documents37 and including Common Data Elements from the NIH guidelines. Exclusion Criteria: - Subjects will be excluded from the study if they have a history of congenital or acquired cognitive or neurological disorders including developmental delay, brain tumor, stroke, or known pre-injury peripheral or central vestibular disorders. In addition, patients who have begun anti-depressant, stimulant or anti-seizure medications for treatment of their symptoms or for other, unrelated reasons within two months of testing will be excluded from testing. Controls and patients with a pre-injury history of Attention Deficit Hyperactivity Disorder (ADHD) or other issues that could confound their ability to complete the proposed tasks will be documented and utilized for further analyses after completion of testing, but these data will not be excluded. |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with impaired performance following concussion | Patients with mTBI will exhibit more variable speed (greater SD) and more lateral deviation variability from the center lane in all tasks, compared to healthy controls. 1.2 Patient with mTBI will exhibit more variable speed (greater SD) and more lateral deviation variability from the center lane in all tasks at testing session 1 compared to testing session 2. 2.1 Patients with mTBI will exhibit longer average response times from the onset of adverse stimuli than healthy controls. 2.2. Patients with mTBI will exhibit longer average response times from the onset of adverse stimuli at testing session 1 compared to testing session 2. 3.1 Patients with mTBI will exhibit fewer refixations (less saccades) and longer lag when tracking stimuli for all tasks, compared to healthy controls. 3.2 Patients with mTBI will exhibit fewer refixations (less saccades) and longer lag when tracking stimuli for all tasks at testing session 1 compared to testing session 2. |
6 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03304327 -
Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)
|
N/A | |
Completed |
NCT05562544 -
EEG Diagnostic for Repetitive Sub-concussive Head Impacts
|
||
Terminated |
NCT02988609 -
Concussion in Rugby Players: a Pilot Study of Neural Recovery Using fMRI
|
N/A | |
Completed |
NCT02710123 -
Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion
|
N/A | |
Terminated |
NCT02100150 -
A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)
|
Phase 2 | |
Active, not recruiting |
NCT01874847 -
PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin
|
Phase 2/Phase 3 | |
Completed |
NCT02262507 -
Concussion Device Audiological Measures
|
N/A | |
Completed |
NCT01903525 -
DHA For The Treatment of Pediatric Concussion Related to Sports Injury
|
Phase 1 | |
Enrolling by invitation |
NCT05948501 -
The Effects of Concussion on Gait and Posture in Individuals With Peripheral Vision Loss
|
||
Withdrawn |
NCT02643836 -
Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
|
N/A | |
Recruiting |
NCT03360786 -
Primary Prevention of Concussion in Youth Ice Hockey Players
|
N/A | |
Recruiting |
NCT03710109 -
Evaluation of an EEG Based Concussion System
|
||
Not yet recruiting |
NCT02930395 -
Blood Biomarkers for the Management of Concussion in Professional Rugby Players
|
N/A | |
Completed |
NCT02268240 -
Care for Post-Concussive Symptoms
|
N/A | |
Completed |
NCT02271451 -
Q-collar and Brain Injury Biomarkers
|
N/A | |
Completed |
NCT02268058 -
Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children
|
N/A | |
Active, not recruiting |
NCT03608722 -
Video Games to Track Cognitive Health
|
N/A | |
Completed |
NCT02556177 -
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
|
N/A | |
Completed |
NCT02660164 -
A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion
|
||
Completed |
NCT02344446 -
Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion
|
N/A |