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

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01850290
• Lead Sponsor: Baylor Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Baylor Research Institute; 🇺🇸 Dallas, Texas, United States