Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02712996
Recruitment Status : Active, not recruiting
First Posted : March 18, 2016
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Michael G. Tramontana, Ph.D., Vanderbilt University

Brief Summary:
The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help children ages 6-16 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 adults with attention deficits caused by TBI have been investigated prior. The exact effects this drug may have on children with attention deficits caused by TBI are not known, but the investigators expect that Vyvanse will be of some help in treating this population as well.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Attention Deficit Disorder Drug: Lisdexamfetamine Drug: Placebo Phase 4

Detailed Description:
Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in children 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment Outcomes With Lisdexamfetamine Dimesylate (Vyvanse) in Children With Traumatic Brain Injury-Related Attention Deficits
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : November 1, 2019


Arm Intervention/treatment
Active Comparator: Vyvanse
Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.
Drug: Lisdexamfetamine
Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.
Other Name: Vyvanse

Placebo Comparator: Placebo
Placebo capsule, 20-70 mg, each morning for 6 weeks.
Drug: Placebo
Placebo capsule, 20-70 mg, each morning for 6 weeks.




Primary Outcome Measures :
  1. Assessing sustained attention and response inhibition in children using Vyvanse versus Placebo by measuring preservations on the 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.


  2. Assessing sustained attention and response inhibition in children using Vyvanse versus Placebo by measuring Hit Reaction Time (RT) Block Change on the 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.


  3. Assessing sustained attention and response inhibition in children using Vyvanse versus Placebo by measuring RT Inter-Stimulus Interval (ISI) on the 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.


  4. Assessing sustained attention and response inhibition in children using Vyvanse versus Placebo by measuring RT Standard Error (SE) on the 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.


  5. Assessing working memory and concentration in children using Vyvanse versus Placebo by measuring performance on the Digit Span subtest of the Wechler Intelligence Scale for Children - Fifth Edition (WISC-V) [ 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.

  6. Assessing severity of symptoms associated with ADHD in children when using Vyvanse versus placebo by administering the Conners-3 Parent and Self-Report Forms [ Time Frame: 12 weeks ]

    The Conners-3 Parent and Self-Report Forms are assessment tools 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.


  7. Assessing executive functioning in children when using Vyvanse versus placebo by administering the Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: 12 weeks ]
    The BRIEF is a standardized rating scale developed to observe everyday behaviors associated with specific domains of the executive functions in children. It is to be administered to children of age and parents of children participating in the study. The scores will be compared within-subject, i.e., when an individual child is taking Vyvanse for six weeks versus when he/she is taking placebo for six weeks, and also between-subject, i.e., collectively comparing executive performance assessment in children with TBI-related attention deficits using Vyvanse versus taking a placebo.



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:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females ages 6 to 16
  • Traumatic brain injury rated as mild/moderate/severe (based on Glasgow Coma Scale, estimated posttraumatic amnesia, indications of intracranial injury on CT scan, etc.)
  • Sustained 2-36 months earlier
  • Considered to be neurologically stable (absence of post-acute symptoms of confusion, disorientation, etc.)
  • Persistent (> 2 months) problems with focused or sustained attention
  • Problems with attention/concentration rated as among the most prominent cognitive changes
  • Accompanying features may include diminished arousal/speed/stamina and/or hyperactivity/impulsivity symptoms.

Exclusion Criteria:

  • Cases with primarily penetrating head trauma
  • Pre-injury history of diagnosed ADHD
  • Pre-injury history of other neurodevelopmental disorders including intellectual disabilities, major communication disorders, autism spectrum disorder
  • Unstable or serious psychiatric conditions, such as psychotic symptoms. Concurrent problems with depression, anxiety, or post-traumatic stress disorder may be present but are judged to be stable and not so severe as to require pharmacologic treatment
  • Treatment with psychotropic medication(s), including psychostimulant(s) within the last 6 months, but eligible thereafter
  • Lifetime history of stimulant abuse or dependence. Other (non-stimulant) substance abuse within the past 6 months.
  • Tics or other contraindications for psychostimulant use including cardiovascular disease, uncontrolled hypertension or hyperthyroidism, glaucoma, agitation, use of an monoamine oxidase (MAO) inhibitor within the past six weeks. Pregnancy would also be an exclusion for girls of childbearing age.
  • Estimated intelligence quotient (IQ) < 70
  • Sensory and/or motor impairment(s) seriously limiting testing options
  • Neurological conditions including uncontrolled epilepsy, degenerative disorders, brain tumor, or stroke
  • Physical condition affecting arousal, activity level, or stamina including uncontrolled thyroid dysfunction, severe or symptomatic anemia, autoimmune or metabolic disorders, untreated moderate/severe sleep apnea, etc.

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): NCT02712996


Locations
Layout table for location information
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
Shire
Investigators
Layout table for investigator information
Principal Investigator: Michael G Tramontana, Ph.D Vanderbilt University

Layout table for additonal information
Responsible Party: Michael G. Tramontana, Ph.D., Associate Professor of Psychiatry and Neurology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02712996     History of Changes
Other Study ID Numbers: TBI 56592
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
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