The Efficacy of Familiar Voice Stimulation During Coma Recovery

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.

Conditions

• Traumatic Brain Injury
• Coma
• Vegetative State
• Minimally Conscious State

Interventions

BEHAVIORAL

Familiar Auditory Sensory Training

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.

BEHAVIORAL

Sham Auditory Sensory Training

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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab

  collaborator OTHER

• Northwestern Memorial Hospital

  collaborator OTHER

• Northwestern University Feinberg School of Medicine

  collaborator OTHER

• VA Office of Research and Development

  lead FED

Principal Investigators

• Theresa LB Pape, DrPH MA BS · Edward Hines Jr. VA Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2012-03-31

Completion

2012-09-30

Countries

• United States

Study Locations