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OpenTrials
Completed

NCT Number: NCT01850290

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

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor Research Institute

Dallas, Texas, 75246, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. John F Kennedy Coma Recovery Scale Revised

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

  2. Functional Independence Measure (FIM)

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

  3. Functional Assessment Measure (FAM)

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

  4. Orientation Log (O-Log)

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • University of Texas Southwestern Medical Center

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 9, 2013
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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