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

This study has been completed.
Sponsor:
Collaborators:
Rehabilitation Institute of Chicago
Northwestern Memorial Hospital
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00557076
First received: November 8, 2007
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Neural Adaptation After Severe Brain Injury be Facilitated?

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change [ Time Frame: Baseline and immediately after treatment ends (6 weeks after Baseline) ] [ Designated as safety issue: No ]
    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:
  • Coma Near Coma Scale [ Time Frame: Baseline and after the 8th CNC assessment (4 weeks after Baseline) ] [ Designated as safety issue: No ]
    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.

  • Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Immediately after treatment ends ] [ Designated as safety issue: No ]
  • Brainstem Auditory Evoked Potentials [ Time Frame: End of Experimental Intervention ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: July 2008
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557076

Locations
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
Rehabilitation Institute of Chicago
Northwestern Memorial Hospital
Feinberg School of Medicine, Northwestern University
Investigators
Principal Investigator: Theresa LB Pape, DrPH MA BS Edward Hines Jr. VA Hospital
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00557076     History of Changes
Other Study ID Numbers: B4951-R
Study First Received: November 8, 2007
Results First Received: October 21, 2014
Last Updated: November 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Randomized Clinical Trial
Auditory Stimulation

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

ClinicalTrials.gov processed this record on November 24, 2014