The Efficacy of Familiar Voice Stimulation During Coma Recovery
Completed · Not applicable · Has a placebo group
Conditions studied: Traumatic Brain Injury, Coma, Vegetative State, Minimally Conscious State
In brief
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.
Key facts
- Study ID
- NCT00557076
- Run by
- VA Office of Research and Development
- People needed
- 21
- Starts
- 2008-07-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2019-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Rehabilitation Institute of Chicago — Chicago, Illinois, United States
- Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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