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

This study has been terminated.
(unable to meet recruitment goals)
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Michael G. Tramontana, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01000064
First received: October 15, 2009
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Traumatic Brain Injury Attention Deficit Disorder Drug: Vyvanse Procedure: fMRI Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Psychostimulant Treatment of TBI-Related Attention Deficits: fMRI Analysis of Neural Mechanisms of Response

Resource links provided by NLM:


Further study details as provided by Michael G. Tramontana, Vanderbilt University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: October 2009
Study Completion Date: May 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
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.

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.

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.
  Eligibility

Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000064

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Shire
Investigators
Principal Investigator: Michael G Tramontana, Ph.D. Vanderbilt University
  More Information

Responsible Party: Michael G. Tramontana, Associate Professor of Psychiatry, Neurology, and Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01000064     History of Changes
Other Study ID Numbers: TBI 090563
Study First Received: October 15, 2009
Results First Received: December 22, 2015
Last Updated: April 10, 2017

Keywords provided by Michael G. Tramontana, Vanderbilt University:
Traumatic Brain Injury
Attention Deficit
TBI

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Attention Deficit Disorder with Hyperactivity
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on June 27, 2017