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

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury; Attention Deficit Disorder

Intervention: Vyvanse (Drug); fMRI (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Michael G Tramontana, Ph.D., Principal Investigator, Affiliation: Vanderbilt University

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.

Clinical Details

Official title: Psychostimulant Treatment of TBI-Related Attention Deficits: fMRI Analysis of Neural Mechanisms of Response

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

Evaluation of which types of patients are most likely to benefit from treatment.

The study will utilize fMRI methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.

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

Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

Vanderbilt University, Nashville, Tennessee 37232, United States
Additional Information

Starting date: October 2009
Last updated: June 3, 2015

Page last updated: August 23, 2015

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