The Efficacy of Familiar Voice Stimulation During Coma Recovery (FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00557076
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : November 10, 2014
Last Update Posted : November 10, 2014
Shirley Ryan AbilityLab
Northwestern Memorial Hospital
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Coma Vegetative State Minimally Conscious State Behavioral: Familiar Voice Stimulation High Dose Behavioral: Sham Auditory Stimulation Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Neural Adaptation After Severe Brain Injury be Facilitated?
Study Start Date : July 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma

Arm Intervention/treatment
Experimental: Arm 1
high dose of familiar voice stimulation
Behavioral: Familiar Voice Stimulation High Dose
The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs.
Other Name: High Dose

Sham Comparator: Arm 2
sham auditory stimulation
Behavioral: Sham Auditory Stimulation
The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence.

Primary Outcome Measures :
  1. DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change [ Time Frame: Baseline and immediately after treatment ends (6 weeks after Baseline) ]
    The primary outcome, the DOCS, is a reliable, valid and precise measure of global neurobehavioral functioning shown to remain stable over six weeks.The DOCS-25 starts with a systematic observation followed by administration of 25 sensory stimuli. Best responses to each stimulus are rated on a scale of 0 to 2 and total raw scores range from 0 (worst) to 50 (best). The DOCS change was calculated as the value at endpoint (6 weeks after Baseline) minus the value at Baseline.

Secondary Outcome Measures :
  1. Coma Near Coma Scale [ Time Frame: Baseline and after the 8th CNC assessment (4 weeks after Baseline) ]
    The CNC scale measures arousal and awareness and test stimuli are administered to elicit a specified behavior. Presence/absence of this behavior is scored as 0, 2 or 4. Total raw scores range from 0 (consistently responsive) to 36 (extreme coma). The CNC change score was calculated as the 8th CNC measure minus the Baseline CNC measure. Since 2 CNC measurements were collected per week, the 8th CNC measure occurred in Week 4. To calculate the change, we used the eighth CNC measure because two patients (one per group) recovered full consciousness after the eighth CNC measure. In the second statistical analysis, all CNC measures were used to calculate the slope; this includes the Baseline CNC and CNC measures 2-8. Again, we used the first 8 CNC measures (instead of all 12 collected over 6 weeks of treatment) because two patients recovered full consciousness after the eighth CNC measure.

  2. Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Immediately after treatment ends ]
  3. Brainstem Auditory Evoked Potentials [ Time Frame: End of Experimental Intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00557076

United States, Illinois
The Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-3030
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
VA Office of Research and Development
Shirley Ryan AbilityLab
Northwestern Memorial Hospital
Feinberg School of Medicine, Northwestern University
Principal Investigator: Theresa LB Pape, DrPH MA BS Edward Hines Jr. VA Hospital

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT00557076     History of Changes
Other Study ID Numbers: B4951-R
First Posted: November 12, 2007    Key Record Dates
Results First Posted: November 10, 2014
Last Update Posted: November 10, 2014
Last Verified: November 2014

Keywords provided by VA Office of Research and Development:
Randomized Clinical Trial
Auditory Stimulation

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Persistent Vegetative State
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms