title: Placebo-Controlled Trial of Familiar Auditory Sensory Training for Acute Severe Traumatic Brain Injury: A Preliminary Report.
abstract: BACKGROUND
  Sensory stimulation is often provided to persons incurring severe traumatic brain injury (TBI), but therapeutic effects are unclear.
  
  
  OBJECTIVE
  This preliminary study investigated neurobehavioral and neurophysiological effects related to sensory stimulation on global neurobehavioral functioning, arousal, and awareness.
  
  
  METHODS
  A double-blind randomized placebo-controlled trial where 15 participants in states of disordered consciousness (DOC), an average of 70 days after TBI, were provided either the Familiar Auditory Sensory Training (FAST) or Placebo of silence. Global neurobehavioral functioning was measured with the Disorders of Consciousness Scale (DOCS). Arousal and awareness were measured with the Coma-Near-Coma (CNC) scale. Neurophysiological effect was measured using functional magnetic resonance imaging (fMRI).
  
  
  RESULTS
  FAST (n = 8) and Placebo (n = 7) groups each showed neurobehavioral improvement. Mean DOCS change (FAST = 13.5, SD = 8.2; Placebo = 18.9, SD = 15.6) was not different, but FAST patients had significantly (P = .049; 95% confidence interval [CI] = -1.51, -.005) more CNC gains (FAST = 1.01, SD = 0.60; Placebo = 0.25, SD = 0.70). Mixed-effects models confirm CNC findings (P = .002). Treatment effect, based on CNC, is large (d = 1.88, 95% CI = 0.77, 3.00). Number needed to treat is 2. FAST patients had more fMRI activation in language regions and whole brain (P values <.05) resembling healthy controls' activation.
  
  
  CONCLUSIONS
  For persons with DOC 29 to 170 days after TBI, FAST resulted in CNC gains and increased neural responsivity to vocal stimuli in language regions. Clinicians should consider providing the FAST to support patient engagement in neurorehabilitation.
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA Northwestern University Feinberg School of Medicine, Chicago, IL, USA Theresa.Pape@va.gov t-pape@northwestern.edu.
authors.forename: Theresa Louise-Bender
authors.initials: TL
authors.lastname: Pape
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL, USA Northwestern Memorial Hospital, Chicago, IL, USA.
authors.forename: Joshua M
authors.initials: JM
authors.lastname: Rosenow
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.
authors.forename: Monica
authors.initials: M
authors.lastname: Steiner
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Todd
authors.initials: T
authors.lastname: Parrish
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA Marianjoy Rehabilitation Hospital, Wheaton, IL, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Guernon
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA.
authors.forename: Brett
authors.initials: B
authors.lastname: Harton
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.
authors.forename: Vijaya
authors.initials: V
authors.lastname: Patil
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA University of Illinois at Chicago, Chicago, IL, USA.
authors.forename: Dulal K
authors.initials: DK
authors.lastname: Bhaumik
authors.affiliation: Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.
authors.forename: Shane
authors.initials: S
authors.lastname: McNamee
authors.affiliation: Northshore University Health Systems, Evanston, IL, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Walker
authors.affiliation: The Rehabilitation Institute of Chicago, Chicago, IL, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Froehlich
authors.affiliation: The Rehabilitation Institute of Chicago, Chicago, IL, USA.
authors.forename: Catherine
authors.initials: C
authors.lastname: Burress
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Odle
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Xue
authors.initials: X
authors.lastname: Wang
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA.
authors.forename: Amy A
authors.initials: AA
authors.lastname: Herrold
authors.affiliation: University of Illinois at Chicago, Chicago, IL, USA.
authors.forename: Weihan
authors.initials: W
authors.lastname: Zhao
authors.affiliation: Edward Hines Jr VA Hospital, Hines, IL, USA.
authors.forename: Domenic
authors.initials: D
authors.lastname: Reda
authors.affiliation: The George Washington University, Washington, DC, USA.
authors.forename: Trudy
authors.initials: T
authors.lastname: Mallinson
authors.affiliation: Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Conneely
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Nemeth
mesh_terms: D000161:Acoustic Stimulation / Q000379:methods*; D000208:Acute Disease; D000328:Adult; D001143:Arousal / Q000502:physiology; D001307:Auditory Perception / Q000502:physiology; D001364:Awareness / Q000502:physiology; D001921:Brain / Q000503:physiopathology*; D001930:Brain Injuries / Q000503:physiopathology* / Q000534:rehabilitation*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D000066530:Neurological Rehabilitation / Q000379:methods*; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: auditory plasticity; disordered consciousness; neurorehabilitation; sensory stimulation; traumatic brain injury; treatment