- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00557076
The Efficacy of Familiar Voice Stimulation During Coma Recovery (FAST)
Can Neural Adaptation After Severe Brain Injury be Facilitated?
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:
- 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, primary auditory area, bilateral pre-frontal cortex, hippocampus and/or the cerebellum post-intervention compared to pre-intervention.
Study Overview
Status
Intervention / Treatment
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 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- The Rehabilitation Institute of Chicago
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Hines, Illinois, United States, 60141-3030
- Edward Hines, Jr. VA Hospital
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Virginia
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Richmond, Virginia, United States, 23249
- Hunter Holmes McGuire VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Familiar Auditory Sensory Training
FAST is a standardized passive auditory stimulation protocol.
The patient is provided with customized recordings of stories told by people well known to the patient at least 1 year prior to injury.
The stories represent specific events experienced by both the patient and the storyteller.
The FAST protocol is provided on compact discs (CDs), using portable players and noise cancelling headphones, while patients were awake (ie, eyes open).
Speakers were used for one patient not tolerating his headphones.
The CDs were identical according to track duration, labeling, and administration procedures.
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Patient is provided with customized recordings of stories told by people well known to the patient at least 1 year prior to injury.
The stories represent specific events experienced by both the patient and the storyteller.
Patients received FAST for 10 minutes 4 times per day, with at least 2 hours in between, for 6 week.
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Sham Comparator: Sham Auditory Sensory Training
Placebo protocol is silence.
Patients receive sham protocols for 10 minutes 4 times per day, with at least 2 hours in between, for 6 weeks.
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The sham intervention is zero minutes of Familiar Auditory Sensory Training.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change
Time Frame: Baseline and immediately after treatment ends (6 weeks after Baseline)
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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.
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Baseline and immediately after treatment ends (6 weeks after Baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coma Near Coma Scale
Time Frame: Baseline and after the 8th CNC assessment (4 weeks after Baseline)
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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.
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Baseline and after the 8th CNC assessment (4 weeks after Baseline)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Theresa LB Pape, DrPH MA BS, Edward Hines Jr. VA Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Neurobehavioral Manifestations
- Brain Damage, Chronic
- Craniocerebral Trauma
- Trauma, Nervous System
- Unconsciousness
- Consciousness Disorders
- Brain Injuries
- Brain Injuries, Traumatic
- Persistent Vegetative State
Other Study ID Numbers
- B4951-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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