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Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits

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: NCT01000064
Recruitment Status : Terminated (unable to meet recruitment goals)
First Posted : October 22, 2009
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Michael G. Tramontana, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE October 15, 2009
First Posted Date  ICMJE October 22, 2009
Results First Submitted Date  ICMJE December 22, 2015
Results First Posted Date  ICMJE May 19, 2017
Last Update Posted Date May 19, 2017
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). [ Time Frame: 12 weeks ]
    Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance.
  • Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). [ Time Frame: 12 weeks ]
    Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Hit Reaction Time (RT) Block Change measures inattention and vigilance. Lower values indicate less slowing in RT as the test progressed. High T-scores indicate decreased vigilance over time.
  • Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II) [ Time Frame: 12 weeks ]
    Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Hit Reaction Time (RT) Inter-Stimulus Interval (ISI) Change assesses the ability to adapt to changing inter-stimulus intervals. Inter-stimulus intervals refers to the amount of time between presentation of stimuli. High t-scores indicate that RT increased as the ISI increased; negative values indicate that RT decreased as the ISI increased. Less Hit RT ISI Change indicates less variability in RT depending on the speed of presentation.
  • Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). [ Time Frame: 12 weeks ]
    Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Hit Reaction Time (RT) Standard Error (SE) measures inattention. Consistency of response times is measured by the standard error for responses to targets. Higher values indicate a greater amount of inattention.
  • Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Wechsler Adult Intelligence Scale -- Fourth Edition (WAIS-IV) Digit Span-Backward Subtest. [ Time Frame: 12 weeks ]
    Digit Span repeats strings of digits of increasing length said by the examiner in the same (forward) and in reverse (backward) order. It measures working memory and concentration with a range of scaled scores from 1-19, with higher scaled scores indicating better performance when compared to population norms.
  • Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Conners Adult ADHD Rating Scale: Long Form (CAARS:L) "Inattention/Memory Problems" Sub-scale. [ Time Frame: 12 weeks ]
    The CAARS:L is an assessment tool that prompts an observer to provide valuable information about the client. This instrument is helpful when considering a diagnosis of ADHD or related problem. High scores on the "Inattention/Memory Problems" sub-scale may indicate difficulty in concentration, difficulty planning or completing tasks, forgetfulness, absent-mindedness, and/or being disorganized. T-scores (M = 50, SD = 10) are used to measure ratings with higher t-scores indicating greater inattention and memory problems. When a t-score is around 60, this indicates greater risk.
  • Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Behaviour Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Organization of Materials" Sub-scale. [ Time Frame: 12 weeks ]
    The BRIEF-A is a standardized rating scale developed to observe everyday behaviors associated with specific domains of the executive functions in adults ages 18 to 90 years. The "Organization of Materials" scale measures orderliness of work, living, and storage spaces. T-scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning on the BRIEF-A, with higher scores indicating more difficulty in a particular area.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
Assessment of various components of attention, related cognitive processes, ADHD symptoms, emotional status, and quality of life ratings using various tests and scales such as Word List learning, ADHD Rating Scale, Beck Depression Inventory, etc. [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Evaluation of Which Types of Patients Are Most Likely to Benefit From Treatment [ Time Frame: 12 weeks ]
  • The Study Will Utilize fMRI Methods (as Well as Aforementioned Neurobehavioral Measures) to Elucidate Neural Mechanisms of Response. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
  • Evaluation of which types of patients are most likely to benefit from treatment. [ Time Frame: 12 weeks ]
  • The study will utilize fMRI methods, as well as neural-behavioral measures, to elucidate neural mechanisms of response. [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits
Official Title  ICMJE Psychostimulant Treatment of TBI-Related Attention Deficits: fMRI Analysis of Neural Mechanisms of Response
Brief Summary The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse will be of some help in treating those types of problems as well. The study will utilize functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.
Detailed Description Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in both children and adults following traumatic brain injury (TBI). These often are among the most prominent symptoms manifested and may contribute to interference in a variety of other functional domains. Although there has been some use of psychostimulant medication to treat TBI-acquired attention deficits, it remains a relatively uncommon clinical practice. This study, by highlighting mechanisms of action, could serve to promote the appropriate use of this type of treatment for the patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Attention Deficit Disorder
Intervention  ICMJE
  • Drug: Vyvanse
    30 mg - 70 mg capsules taken every morning for 6 weeks.
  • Procedure: fMRI
    Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
    Other Name: functional magnetic resonance imaging
  • Drug: Placebo
    Placebo capsules taken every morning for 6 weeks.
Study Arms  ICMJE
  • Active Comparator: Vyvanse

    Vyvanse capsule, 30-70 mg, each morning for 6 weeks.

    Placebo capsule each morning for 6 weeks.

    Brain scans (fMRI) performed at baseline, 6th week visit and 12th week visit.

    Interventions:
    • Drug: Vyvanse
    • Procedure: fMRI
    • Drug: Placebo
  • Placebo Comparator: Placebo

    Vyvanse capsule, 30-70 mg, each morning for 6 weeks.

    Placebo capsule each morning for 6 weeks.

    Brain scans (fMRI) performed at baseline, 6th week visit and 12th week visit.

    Interventions:
    • Drug: Vyvanse
    • Procedure: fMRI
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 3, 2015)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2009)
20
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females, ages 16 to 45
  • Closed head injury rated as moderate/severe (based on Glasgow Coma Scale rating, estimated posttraumatic amnesia, etc.)
  • Sustained 6 to 36 months earlier, and considered to be neurologically stable
  • Persistent (> 6 months) problems with focused or sustained attention (+1 SD or worse on Inattention component of ADHD self ratings) corroborated by professional staff (nurses, therapists, etc.) or caregivers. Problems with attention/concentration rated as among most prominent cognitive changes.
  • Accompanying features may include diminished arousal/speed/stamina and/or disinhibited symptoms

Exclusion Criteria:

  • Penetrating head injury
  • Pre-injury history of diagnosed ADHD
  • Other psychiatric conditions such as mania or psychosis. Current posttraumatic stress disorder (PTSD) symptoms may be present but not so severe as to require pharmacologic treatment.
  • Lifetime history of psychostimulant abuse or dependence. Other (non-psychostimulant) substance abuse within the past 6 months. Total lifetime drug use will not exceed 5 times each for substances such as amphetamine, meth-amphetamine, or cocaine.
  • Prior treatment with psychostimulant(s)
  • Tics or other contraindications for psychostimulant use including arteriosclerosis, cardiovascular disease, uncontrolled hypertension or hyperthyroidism, glaucoma, agitation, use of MAO inhibitor within 6 weeks
  • Current treatment with other psychotropic medication(s) within the past 6 weeks
  • Estimated IQ < 80
  • Sensory and/or motor impairment(s) seriously limiting testing options
  • Other neurological conditions including epilepsy, degenerative disorders, brain tumor, or stroke.
  • Physical conditions affecting arousal, activity level or stamina, including uncontrolled thyroid dysfunction, anemia, autoimmune or metabolic disorders, untreated moderate/severe sleep apnea, etc.
  • Persons for whom MRI scanning is contraindicated, including weight greater than 275 pounds (due to scanner table limitations), severe claustrophobia, implanted electronic medical devices (e.g. pacemaker, cochlear or other inner ear implant, deep brain stimulator), metallic foreign object in eye or rest of the body, history of sheet metal work, aneurysm clips, non-removable metallic piercings, and dental prosthetics.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000064
Other Study ID Numbers  ICMJE TBI 090563
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael G. Tramontana, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Shire
Investigators  ICMJE
Principal Investigator: Michael G Tramontana, Ph.D. Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP