Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 39 for:    "Brain Injury" | "Dopamine"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01850290
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
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.

Condition or disease
Traumatic Brain Injury

Layout table for study information
Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
Actual Study Start Date : May 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Dopamine Imaging



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Traumatic Brain Injury patients in Inpatient Rehabilitation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850290


Locations
Layout table for location information
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Shahid Shafi, MD Baylor Research Institute
Principal Investigator: Devous Michael, PhD University of Texas Southwestern Medical Center

Layout table for additonal information
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01850290     History of Changes
Other Study ID Numbers: 012-277
H133A120098 ( Other Grant/Funding Number: NIDRR )
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Keywords provided by Baylor Research Institute:
TBI
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Dopamine
Dopamine Agents
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents