Traumatic Brain Injury
Conditions
Keywords
TBI
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.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
Baylor Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability Rating Scale | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks | The primary outcome measure will be the change in Disability Rating Scale over 4 weeks. The Disability Rating Scale is a commonly used and reliable instrument for monitoring minor changes occurring throughout the course of a patient's recovery (Rappaport et al., 1982). |
Secondary
| Measure | Time frame |
|---|---|
| John F Kennedy Coma Recovery Scale Revised | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Functional Independence Measure (FIM) | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Functional Assessment Measure (FAM) | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Orientation Log (O-Log) | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
Countries
United States
Outcome results
None listed