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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 Revised

Functional 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

Page last updated: August 23, 2015

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