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The Efficacy of Familiar Voice Stimulation During Coma Recovery

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: February 14, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) [ Time Frame: Immediately after treatment ends ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: 20
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 three study cohorts and each group receives standard rehabilitation. The experimental group or High-Dose Group will, in addition to standard rehabilitation, be exposed daily to 40 minutes of FVs for 6 weeks. The Low-Dose Group (Control Group 1) will receive standard rehabilitation plus 5 minutes of FVs and 35 minutes of sham treatment daily for 6 weeks. The Sham Group (Control Group 2) will receive standard rehabilitation plus 40 minutes of sham treatment daily for 6 weeks.

The 40 minutes of FVs treatment will be provided in four 10 minutes 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
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
Department of Veterans Affairs
Rehabilitation Institute of Chicago
Northwestern Memorial Hospital
Feinberg School of Medicine, Northwestern University
Investigators
Principal Investigator: Theresa LB Pape, BS MA DrPH 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
Last Updated: February 14, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 23, 2013