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NCT00557076 · ClinicalTrials.gov registry record · NA
The Efficacy of Familiar Voice Stimulation During Coma Recovery
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT00557076: Completed NA study, sponsored by VA Office of Research and Development.
NCT00557076 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00557076, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Familiar Auditory Sensory Training
- BEHAVIORAL Sham Auditory Sensory Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-09 |
| Phase | NA |
What the finished NCT00557076 record still lists
NCT00557076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Familiar Auditory Sensory Training is the first listed.
NCT00557076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00557076 about?
NCT00557076 is a clinical study titled "The Efficacy of Familiar Voice Stimulation During Coma Recovery". 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 Voi...
What is the current status of trial NCT00557076?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2008-07. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00557076?
The interventions under investigation include: Familiar Auditory Sensory Training (BEHAVIORAL), Sham Auditory Sensory Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT00557076?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00557076's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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