Status:
COMPLETED
Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
University of Texas Southwestern Medical Center
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-50 years
Brief Summary
This study will examine resting dopamine function as well as dopamine response in the brain as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI) patients.
Eligibility Criteria
Inclusion
- Non-penetrating TBI
- Age between 18-50 years old
- Admitted to a North Texas TBI Model Systems-affiliated rehabilitation facility within 16 weeks of injury
- Rated at Rancho VI Los Amigos Levels of Cognitive Functioning Scale of less than or equal to Stage V at the time of enrollment
- Disability Rating Scale total score \>/= 7
Exclusion
- Central Nervous System disorder resulting in functional disability predating TBI
- Documented diagnosis of disease processes impacted by the dopamine system (e.g., Parkinson's Disease, clinician diagnosed Attention Deficit Hyperactivity Disorder, substance abuse/dependence (excluding marijuana, alcohol, tobacco), or schizophrenia)
- Pre-injury use of dopaminergic pharmaceuticals (i.e., methylphenidate, amantadine, or dopamine receptor blockers such as olanzapine or quetiapine)
- Documented contraindication to use of methylphenidate including allergy
- Uncontrolled epilepsy
- Pregnant
- Medical condition not compatible with use of Methylphenidate
- Recent diagnosis or therapeutic study using radiopharmaceuticals
- Contraindications to the use of Ioflupane
- Allergic to Iodine
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01850290
Start Date
May 1 2013
End Date
March 1 2016
Last Update
February 5 2018
Active Locations (1)
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1
Baylor Research Institute
Dallas, Texas, United States, 75246