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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Dopamine Imaging

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No