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

Last updated: April 10, 2017
Sponsor: Vanderbilt University
Overall Status: Terminated

Phase

3

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Attention Deficit/hyperactivity Disorder (Adhd - Pediatric)

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT01000064
TBI 090563
  • Ages 16-45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 worseon Inattention component of ADHD self ratings) corroborated by professional staff (nurses, therapists, etc.) or caregivers. Problems with attention/concentration ratedas among most prominent cognitive changes.

  • Accompanying features may include diminished arousal/speed/stamina and/or disinhibitedsymptoms

Exclusion

Exclusion Criteria:

  • Penetrating head injury

  • Pre-injury history of diagnosed ADHD

  • Other psychiatric conditions such as mania or psychosis. Current posttraumatic stressdisorder (PTSD) symptoms may be present but not so severe as to require pharmacologictreatment.

  • Lifetime history of psychostimulant abuse or dependence. Other (non-psychostimulant)substance abuse within the past 6 months. Total lifetime drug use will not exceed 5times 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, includinguncontrolled thyroid dysfunction, anemia, autoimmune or metabolic disorders, untreatedmoderate/severe sleep apnea, etc.

  • Persons for whom MRI scanning is contraindicated, including weight greater than 275pounds (due to scanner table limitations), severe claustrophobia, implanted electronicmedical devices (e.g. pacemaker, cochlear or other inner ear implant, deep brainstimulator), metallic foreign object in eye or rest of the body, history of sheetmetal work, aneurysm clips, non-removable metallic piercings, and dental prosthetics.

Study Design

Total Participants: 22
Study Start date:
October 01, 2009
Estimated Completion Date:
May 31, 2015

Study 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.

Connect with a study center

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

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