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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850290
• Other study ID #: 012-277
• Secondary ID: H133A120098
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: February 2, 2018
• Start date: May 2013
• Est. completion date: March 2016

Study information

• Verified date: February 2018
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Baylor Research Institute	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Disability Rating Scale	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).	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	John F Kennedy Coma Recovery Scale Revised		Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	Functional Independence Measure (FIM)		Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	Functional Assessment Measure (FAM)		Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	Orientation Log (O-Log)		Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks