Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)

Baylor Research Institute1 site in 1 country18 target enrollmentMay 2013

ConditionsTraumatic Brain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Traumatic Brain Injury
Sponsor: Baylor Research Institute
Enrollment: 18
Locations: 1
Primary Endpoint: Change in Disability Rating Scale
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

March 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Baylor Research Institute

Responsible Party

Sponsor

Eligibility 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
•Medical condition not compatible with use of Methylphenidate
•Recent diagnosis or therapeutic study using radiopharmaceuticals
•Contraindications to the use of Ioflupane
•Allergic to Iodine

Outcomes

Primary Outcomes

Change in Disability Rating Scale

Time Frame: 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 Outcomes

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)