The Efficacy of Familiar Voice Stimulation During Coma Recovery

NCT00557076 | Completed Results DMC

• 1 other identifier: B4951-R
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief 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. 1.Significantly more neurobehavioral functioning post-intervention compared to pre-intervention.
2. 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

Keywords

Randomized Clinical Trial; Auditory Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Coma Near Coma Scale

  Baseline and after the 8th CNC assessment (4 weeks after Baseline)

Study Arms (2)

Familiar Auditory Sensory Training

EXPERIMENTAL

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.

Behavioral: Familiar Auditory Sensory Training

Sham Auditory Sensory Training

SHAM COMPARATOR

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.

Behavioral: Sham Auditory Sensory Training

Interventions

Familiar Auditory Sensory Training BEHAVIORAL

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.

Familiar Auditory Sensory Training

Sham Auditory Sensory Training BEHAVIORAL

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.

Sham Auditory Sensory Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe brain injury of traumatic origin
• Non-brain penetrating gun shot wound
• Blunt trauma with subsequent closed head injuries such as diffuse axonal injury
• years of age or older
• Unconscious for at least 28 days consecutively
• Medically Stable
• Does not have active seizures

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Shirley Ryan AbilityLab: collaborator
• Northwestern Memorial Hospital: collaborator
• Northwestern University Feinberg School of Medicine: collaborator

Study Sites (3)

The Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-3030, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (2)

• 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.

  PMID: 23341285 RESULT

• 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.

  PMID: 25613986 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Coma; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic

Limitations and Caveats

A limitation is achieved sample size. Given restrictive eligibility criteria, enrollment was lower than planned.

Results Point of Contact

• Title: Dr. Theresa Pape
• Organization: Edward Hines, Jr VA Hospital

Theresa.Pape@va.gov

708-202-4953

Study Officials

• Theresa LB Pape, DrPH MA BS

  Edward Hines Jr. VA Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 12, 2007
• Study Start: July 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2012
• Last Updated: June 6, 2019
• Results First Posted: November 10, 2014

Record last verified: 2019-03

Locations

US (3)