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Randomized Controlled Trial
. 2015 Jul;29(6):537-47.
doi: 10.1177/1545968314554626. Epub 2015 Jan 22.

Placebo-Controlled Trial of Familiar Auditory Sensory Training for Acute Severe Traumatic Brain Injury: A Preliminary Report

Theresa Louise-Bender Pape  1 , Joshua M Rosenow  2 , Monica Steiner  3 , Todd Parrish  4 , Ann Guernon  5 , Brett Harton  6 , Vijaya Patil  3 , Dulal K Bhaumik  7 , Shane McNamee  8 , Matthew Walker  9 , Kathleen Froehlich  10 , Catherine Burress  10 , Cheryl Odle  6 , Xue Wang  4 , Amy A Herrold  6 , Weihan Zhao  11 , Domenic Reda  6 , Trudy Mallinson  12 , Mark Conneely  13 , Alexander J Nemeth  4
Affiliations
Randomized Controlled Trial

Placebo-Controlled Trial of Familiar Auditory Sensory Training for Acute Severe Traumatic Brain Injury: A Preliminary Report

Theresa Louise-Bender Pape et al. Neurorehabil Neural Repair. 2015 Jul.

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.

Trial registration: ClinicalTrials.gov NCT00557076.

Keywords: auditory plasticity; disordered consciousness; neurorehabilitation; sensory stimulation; traumatic brain injury; treatment.

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