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

This study has been completed.
Information provided by (Responsible Party):
Michael G. Tramontana, Vanderbilt University Identifier:
First received: October 15, 2009
Last updated: June 3, 2015
Last verified: June 2015
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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 Vanderbilt University:

Primary Outcome Measures:
  • 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 ]

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

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.

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

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.
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Please refer to this study by its identifier: NCT01000064

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
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 Identifier: NCT01000064     History of Changes
Other Study ID Numbers: TBI 090563
Study First Received: October 15, 2009
Last Updated: June 3, 2015

Keywords provided by Vanderbilt University:
Traumatic Brain Injury
Attention Deficit

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 processed this record on April 28, 2017