Clinical trial NCT02712996: Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children
Official title: Treatment Outcomes With Lisdexamfetamine Dimesylate (Vyvanse) in Children With Traumatic Brain Injury-Related Attention Deficits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Traumatic Brain Injury
Attention Deficit Disorder
Keywords: Traumatic Brain Injury
Attention Deficit
TBI
Vyvanse
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2016-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Assessing Severity of Symptoms Associated With Attention-deficit/Hyperactivity Disorder (ADHD) in Children When Using Vyvanse Versus Placebo by Administering the Conners-3 Parent Form
timeFrame: 12 weeks
measure: Assessing Executive Functioning in Children When Using Vyvanse Versus Placebo by Administering the Behavior Rating Inventory of Executive Function (BRIEF) - PARENT
timeFrame: 12 weeks
measure: Assessing Inattentiveness in Children Using Vyvanse Versus Placebo by Measuring Omissions on the Conners Continuous Performance Task (CPT-II).
timeFrame: 12 weeks
measure: Assessing Physical Symptoms in Children Using Vyvanse Versus Placebo by Measuring Anxiety on the Revised Child Manifest Anxiety Scale (RCMAS)
timeFrame: 12 weeks
measure: Assessing Total Symptoms in Children Using Vyvanse Versus Placebo by Measuring Anxiety on the Revised Child Manifest Anxiety Scale (RCMAS)
timeFrame: 12 weeks
measure: Assessing Attention Problems in Children Using Vyvanse Versus Placebo by Measuring Symptoms on the Child Behavior Checklist (CBCL)
timeFrame: 12 weeks
measure: Assessing Anxiety-Depression Problems in Children Using Vyvanse Versus Placebo by Measuring Symptoms on the Child Behavior Checklist (CBCL)
timeFrame: 12 weeks
measure: Assessing Inhibitory Control in Children When Using Vyvanse Versus Placebo Utilizing the Inhibit Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS
timeFrame: 12 weeks
measure: Assessing Ability to Tolerate Change in Children When Using Vyvanse Versus Placebo by Utilizing the Shift Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS
timeFrame: 12 weeks
measure: Assessing Ability to Begin Tasks in Children When Using Vyvanse Versus Placebo by Utilizing the Initiate Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS
timeFrame: 12 weeks
measure: Assessing Representational Memory in Children When Using Vyvanse Versus Placebo by Utilizing the Working Memory Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS
timeFrame: 12 weeks
measure: Assessing Task-oriented Monitoring in Children When Using Vyvanse Versus Placebo by Utilizing the Monitor Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS
timeFrame: 12 weeks
measure: Assessing Behavior Regulation in Children When Using Vyvanse Versus Placebo by Measuring the Behavior Regulation Index (BRI) on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS
timeFrame: 12 weeks
measure: Assessing Cognitive Regulation in Children When Using Vyvanse Versus Placebo by Measuring the Cognitive Regulation Index (CRI) on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS
timeFrame: 12 weeks
measure: Assessing Emotion Regulation in Children When Using Vyvanse Versus Placebo by Measuring the Emotion Regulation Index (ERI) on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS
timeFrame: 12 weeks
measure: Assessing Hyperactivity in Children When Using Vyvanse Versus Placebo by Administering the Conners-3 Parent Form
timeFrame: 12 weeks
measure: Assessing Executive Functioning in Children When Using Vyvanse Versus Placebo by Administering the Conners-3 Parent Form
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessing Executive Functioning in Children When Using Vyvanse Versus Placebo by Administering the Behavior Rating Inventory of Executive Function (BRIEF) - CHILD SELF REPORT
timeFrame: 12 weeks
measure: Assessing Working Memory and Concentration in Children Using Vyvanse Versus Placebo by Measuring Performance on the Digit Span Subtest of the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V)
timeFrame: 12 weeks
measure: Assessing Sustained Attention and Response Inhibition in Children Using Vyvanse Versus Placebo by Measuring Reaction Time (RT) Standard Error (SE) on the Conners Continuous Performance Task (CPT-II).
timeFrame: 12 weeks
measure: 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).
timeFrame: 12 weeks
measure: 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).
timeFrame: 12 weeks
measure: Assessing Sustained Attention and Response Inhibition in Children Using Vyvanse Versus Placebo by Measuring Perseverations on the Conners Continuous Performance Task (CPT-II).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Michael G Tramontana, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: