Clinical trial NCT00557076: The Efficacy of Familiar Voice Stimulation During Coma Recovery
Official title: Can Neural Adaptation After Severe Brain Injury be Facilitated?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Coma
Vegetative State
Minimally Conscious State
Keywords: Randomized Clinical Trial
Auditory Stimulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Shirley Ryan AbilityLab
name: Northwestern Memorial Hospital
name: Northwestern University Feinberg School of Medicine
First posted: 2007-11-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Medical advances have improved the odds of surviving a severe traumatic brain injury (TBI) thereby increasing demands for rehabilitation. Medical rehabilitation management during coma recovery, however, has been hampered by a paucity of rigorous clinical trials examining rehabilitation effectiveness. This randomized clinical trial addresses this knowledge gap. The purpose of the study is to determine whether a high dose of familiar vocal stimulation (FVs) improves outcomes for persons who are unconscious after severe TBI. The research objectives are to:

1. Determine whether neural responses elicited with FVs improve neurobehavioral outcomes and/or elicit activations in expected regions.
2. Examine the relationship between neurobehavioral and neurophysiological responses to high doses of FVs during coma recovery.

There are two study cohorts and each group receives standard rehabilitation. The experimental group will be exposed daily to 40 minutes of FVs for 6 weeks. The Sham Group (Control Group 2) will receive 40 minutes of sham treatment, or silence, daily for 6 weeks.

The 40 minutes of FVs treatment will be provided in four 10 minute sessions. Each FV session will start with the subject hearing a familiar voice call the 'Subject's Own Name' aloud and then that same voice re-telling a memory or an event familiar to the subject. The person re-telling the event will be a person who experienced the event with the subject and who interacted with the subject on a daily basis for at least 1 year prior to injury.

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.

Primary outcomes:
measure: DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change
timeFrame: Baseline and immediately after treatment ends (6 weeks after Baseline)
Secondary outcomes:
measure: Coma Near Coma Scale
timeFrame: Baseline and after the 8th CNC assessment (4 weeks after Baseline)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The Rehabilitation Institute of Chicago
state: Illinois
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Edward Hines Jr. VA Hospital
name: Theresa LB Pape, DrPH MA BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pape TL, Rosenow JM, Harton B, Patil V, Guernon A, Parrish T, Froehlich K, Burress C, McNamee S, Herrold AA, Weiss B, Wang X. Preliminary framework for Familiar Auditory Sensory Training (FAST) provided during coma recovery. J Rehabil Res Dev. 2012;49(7):1137-52. doi: 10.1682/jrrd.2011.08.0154.
citation: Pape TL, Rosenow JM, Steiner M, Parrish T, Guernon A, Harton B, Patil V, Bhaumik DK, McNamee S, Walker M, Froehlich K, Burress C, Odle C, Wang X, Herrold AA, Zhao W, Reda D, Mallinson T, Conneely M, Nemeth AJ. Placebo-Controlled Trial of Familiar Auditory Sensory Training for Acute Severe Traumatic Brain Injury: A Preliminary Report. Neurorehabil Neural Repair. 2015 Jul;29(6):537-47. doi: 10.1177/1545968314554626. Epub 2015 Jan 22.