Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
Information source: Baylor Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury
Phase: N/A
Status: Recruiting
Sponsored by: Baylor Research Institute Official(s) and/or principal investigator(s): Shahid Shafi, MD, Principal Investigator, Affiliation: Baylor Research Institute Devous Michael, PhD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center
Overall contact: Libby Callender, Phone: 214-820-9988, Email: librada.callender@baylorhealth.edu
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.
Clinical Details
Official title: Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Change in Disability Rating Scale
Secondary outcome: John F Kennedy Coma Recovery Scale RevisedFunctional Independence Measure (FIM) Functional Assessment Measure (FAM) Orientation Log (O-Log)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Libby Callender, Phone: 214-820-9988, Email: librada.callender@baylorhealth.edu
Baylor Research Institute, Dallas, Texas 75246, United States; Recruiting Libby Callender, Phone: 214-820-9988, Email: libradacallender@baylorhealth.edu Cindy Dunklin, Phone: 214-820-9640, Email: cynthidu@baylorhealth.edu Shahid Shafi, MD, MPH, Principal Investigator
Additional Information
Starting date: May 2013
Last updated: February 9, 2015
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