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

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.

Preliminary framework for Familiar Auditory Sensory Training (FAST) provided during coma recovery.

Since there remains a need to examine the nature of the neural effect and therapeutic efficacy/effectiveness of sensory stimulation provided to persons in states of seriously impaired consciousness, a passive sensory stimulation intervention, referred to as the Familiar Auditory Sensory Training (FAST) protocol, was developed for examination in an ongoing, double-blind, randomized clinical trial (RCT). The FAST protocol is described in this article according to the preliminary framework, which is a synthesis of knowledge regarding principles of plasticity and capabilities of the human brain to automatically and covertly process sensory input. Feasibility issues considered during the development of the intervention are also described.