The Efficacy of Familiar Voice Stimulation During Coma Recovery

Traumatic Brain Injury Clinical Trial

— FAST  

Official title:

Can Neural Adaptation After Severe Brain Injury be Facilitated?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557076
• Other study ID #: B4951-R
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: September 2012

Study information

• Verified date: March 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Determine whether neural responses elicited with FVs improve neurobehavioral outcomes and/or elicit activations in expected regions.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Coma
• Minimally Conscious State
• Persistent Vegetative State
• Traumatic Brain Injury
• Vegetative State

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Feinberg School of Medicine, Northwestern University, Northwestern Memorial Hospital, Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change	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.	Baseline and immediately after treatment ends (6 weeks after Baseline)
Secondary	Coma Near Coma Scale	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.	Baseline and after the 8th CNC assessment (4 weeks after Baseline)