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

NCT01850290 | Completed

• 2 other identifiers: 012-277H133A120098
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

TBI

Outcome Measures

Primary Outcomes (1)

• Change in Disability Rating Scale

  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 Outcomes (4)

• John F Kennedy Coma Recovery Scale Revised

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

• Functional Independence Measure (FIM)

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

• Functional Assessment Measure (FAM)

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

• Orientation Log (O-Log)

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Study Arms (1)

Dopamine Imaging

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic Brain Injury patients in Inpatient Rehabilitation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Shahid Shafi, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

• Devous Michael, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 9, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (1)