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

February 2, 2018 updated by: Baylor Research Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Traumatic Brain Injury patients in Inpatient Rehabilitation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Dopamine Imaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
John F Kennedy Coma Recovery Scale Revised
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Functional Independence Measure (FIM)
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Functional Assessment Measure (FAM)
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Orientation Log (O-Log)
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Texas Southwestern Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shahid Shafi, MD, Baylor Research Institute
  • Principal Investigator: Devous Michael, PhD, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 012-277
  • H133A120098 (Other Grant/Funding Number: NIDRR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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