The Efficacy of Familiar Voice Stimulation During Coma Recovery - Full Text View

Sponsors and Collaborators:	Department of Veterans Affairs Rehabilitation Institute of Chicago Northwestern Memorial Hospital Feinberg School of Medicine, Northwestern University
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00557076

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 low-dose of FVs (Low Dose Group) and/or unconscious persons receiving SR and sham stimulation (Sham Group) will demonstrate:

Significantly more neurobehavioral functioning post-intervention compared to pre-intervention.
Using Functional Magnetic Resonance Imaging (fMRI), significantly higher average measures of volumetric activity in the whole brain, middle temporal gyrus bilaterally, pri-mary 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: Familiar Voice Stimulation Low Dose Behavioral: Sham Auditory Stimulation	Phase I Phase II

MedlinePlus related topics: MRI Scans Rehabilitation Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Can Neural Adaptation After Severe Brain Injury be Facilitated?

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 ]

Estimated Enrollment:	45
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator low dose of familiar voice stimulaiton	Behavioral: Familiar Voice Stimulation Low Dose The Low Dose intervention is 210 minutes of Familiar Voice Stimulation is provided in 5 minute daily segments for 6 weeks. One CD with 5 minutes of Familiar Voice Stimulation preceded by the familiar voice calling out the Subject's name then followed by a recording of silence for 5 minutes will be played 1 time each day for 6 weeks. Three other CDs with 10 minutes of silence recorded on each CD will also be played 1 time per day for 6 weeks.
3: Sham Comparator sham auditory stimulaiton	Behavioral: Sham Auditory Stimulation The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulatin will b e 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:

Determine whether neural responses elicited with FVs improve neurobehavioral outcomes and/or elicit activations in expected regions.
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 180 days post injury
MRI is contraindicated (e.g., metal, titanium in brain)
Ventilator dependent
Cardiac contraindications
Patient is a recipient of seizure prophylaxis due to active seizures as diagnosed be treating physician
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

Contacts

Contact: Ann Guernon, MS	(630) 909-7146	aguernon@marianjoy.org
Contact: Cheryl C Odle, MBA	(708) 202-8387 ext 23117	cheryl.odle@va.gov

Locations

United States, Illinois
Edward Hines, Jr. VA Hospital	Recruiting
Hines, Illinois, United States, 60141-3030
Contact: Ann Guernon, MS 630-909-7146 aguernon@marianjoy.org
Contact: Cheryl C Odle, MBA (708) 202-8387 ext 23117 cheryl.odle@va.gov
Principal Investigator: Theresa Louise-Bender Pape, BS MA DrPH
The Rehabilitation Institute of Chicago	Recruiting
Chicago, Illinois, United States, 60611
Contact: Julie Fuith, MS 312-238-1900 jfuith@ric.org
United States, Virginia
Hunter Holmes McGuire VA Medical Center	Recruiting
Richmond, Virginia, United States, 23249
Contact: Shane Mcnamee, MD 804-675-5117 shane.mcnamee@va.gov

Sponsors and Collaborators

Department of Veterans Affairs

Rehabilitation Institute of Chicago

Northwestern Memorial Hospital

Feinberg School of Medicine, Northwestern University

Investigators

Principal Investigator:

Theresa Louise-Bender Pape, BS MA DrPH

Edward Hines Jr. VA Hospital

More Information

Additional Information:

Click here for more information about this study: Can Neural Adaptation after Severe Brain Injury be Facilitated? This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Department of Veterans Affairs ( Pape, Theresa - Principal Investigator )
Study ID Numbers:	B4951R
Study First Received:	November 8, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00557076 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Randomized Clinical Trial
Auditory Stimulation

Study placed in the following topic categories:

Persistent Vegetative State
Craniocerebral Trauma
Unconsciousness
Brain Damage, Chronic
Consciousness Disorders
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Coma
Signs and Symptoms
Neurologic Manifestations
Brain Injuries
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Persistent Vegetative State
Craniocerebral Trauma
Unconsciousness
Brain Damage, Chronic
Consciousness Disorders
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Coma
Signs and Symptoms
Neurologic Manifestations
Brain Injuries
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on May 07, 2009