N/A N=16 Randomized Quadruple-blind Treatment

The Efficacy of Familiar Voice Stimulation During Coma Recovery

Traumatic Brain Injury · Coma · Vegetative State · Minimally Conscious State

Bottom Line

View on ClinicalTrials.gov: NCT00557076 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change — 13.5; 18.9 units on a scale — p=.465

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Familiar Auditory Sensory Training (Behavioral); Sham Auditory Sensory Training (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change	13.5; 18.9	.465
SECONDARY Coma Near Coma Scale	1.0; 0.25	0.049 sig

Summary

The purpose of the study is to determine whether familiar vocal stimulation, provided during coma recovery, improves outcomes for persons who are unconscious after severe TBI. The primary hypothesis is that unconscious persons who receive standard rehabilitation (SR) plus a high-dose of Familiar Voice stimulation (FVs) compared to unconscious persons who receive SR plus a sham stimulation (Sham Group) will demonstrate: 1. Significantly more neurobehavioral functioning post-intervention compared to pre-intervention. 2. Using Functional Magnetic Resonance Imaging (fMRI), significantly higher average measures of volumetric activity in the whole brain, middle temporal gyrus bilaterally, primary auditory area, bilateral pre-frontal cortex, hippocampus and/or the cerebellum post-intervention compared to pre-intervention.

Eligibility Criteria

Inclusion Criteria

Severe brain injury of traumatic origin
Non-brain penetrating gun shot wound
Blunt trauma with subsequent closed head injuries such as diffuse axonal injury
18 years of age or older
Unconscious for at least 28 days consecutively
Medically Stable
Does not have active seizures

Exclusion Criteria

History of brain injury
More than 1 year post injury
MRI is contraindicated (e.g., metal, titanium in brain)
Ventilator dependent
Cardiac contraindications
The definition of traumatic brain injury excludes: (a) Lacerations or contusions of the face, eye, ear or scalp and fractures of facial bones with-out loss of consciousness; (b) Primary cause of injury is blunt trauma (e.g., contusion from blow to head) without subsequent closed head injuries such as contra coup or diffuse axonal injury; (c) Brain-penetrating gun shot wound; (d) Primary BI due to anoxic, inflammatory, infectious, toxic metabolic encephalopathies; (e) Cancer, brain infarction (ischemic stroke), intracranial hemorrhage (hemorrhagic stroke) aneurysms and arterio-venous malformations.

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Data sourced from ClinicalTrials.gov (NCT00557076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.