The Efficacy of Familiar Voice Stimulation During Coma Recovery (FAST)
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|ClinicalTrials.gov Identifier: NCT00557076|
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : November 10, 2014
Last Update Posted : November 10, 2014
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.
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Immediately after treatment ends ]
- Brainstem Auditory Evoked Potentials [ Time Frame: End of Experimental Intervention ]
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 ClinicalTrials.gov 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|
|Principal Investigator:||Theresa LB Pape, DrPH MA BS||Edward Hines Jr. VA Hospital|