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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Michael G. Tramontana, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01000064
First received: October 15, 2009
Last updated: June 25, 2013
Last verified: June 2013
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of which types of patients are most likely to benefit from treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The study will utilize fMRI methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated 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
Other Name: Vyvanse
Procedure: fMRI
Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Other Names:
  • fMRI
  • 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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
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

No publications provided

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
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Traumatic Brain Injury
Attention Deficit
TBI

Additional relevant MeSH terms:
Brain Injuries
Attention Deficit Disorder with Hyperactivity
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014