Traumatic Brain InjuryFASTNCT00557076
The Efficacy of Familiar Voice Stimulation During Coma Recovery
A study testing Familiar Auditory Sensory Training in people with Traumatic Brain Injury and Coma, run by VA Office of Research and Development at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Coma, Vegetative State
- What is being tested?
- Familiar Auditory Sensory Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-3030
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
Official title: Can Neural Adaptation After Severe Brain Injury be Facilitated?
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.
Read the detailed 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:
- 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.
- Being tested
- Familiar Auditory Sensory Training, Sham Auditory Sensory Training
- Keywords
- Randomized Clinical Trial, Auditory Stimulation
- Medical subject headings
- Brain Injuries, Traumatic, Coma, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familiar Auditory Sensory TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham Auditory Sensory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after treatment ends (6 weeks after Baseline)
Secondary outcomes (1)
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.
Measured: Baseline and after the 8th CNC assessment (4 weeks after Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startJul 2008
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Shirley Ryan AbilityLab, Northwestern Memorial Hospital, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Theresa LB Pape, DrPH MA BS, Principal investigator, Edward Hines Jr. VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557076
- Sponsor's protocol ID
- B4951-R
- Acronym
- FAST
- Status last verified
- Mar 2019
- First submitted
- 8 Nov 2007
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23341285Pape 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.
PubMed 25613986
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Neural Adaptation After Severe Brain Injury be Facilitated?
- ClinicalTrials.gov ID
- NCT00557076
- Acronym / sponsor ID
- FAST / B4951-R
- Keywords
- Randomized Clinical Trial, Auditory Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Shirley Ryan AbilityLab, Northwestern Memorial Hospital, Northwestern University
- Study start
- Jul 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 10 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familiar Auditory Sensory Training | Experimental | Behavioral: Familiar Auditory Sensory TrainingFAST 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. |
| Sham Auditory Sensory Training | Sham comparator | Behavioral: Sham Auditory Sensory TrainingPlacebo protocol is silence. Patients receive sham protocols for 10 minutes 4 times per day, with at least 2 hours in between, for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- History of brain injury
- More than 1 year post injury
- MRI is contraindicated (e.g., metal, titanium in brain)
- Ventilator dependent
- Cardiac contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Familiar Auditory Sensory TrainingPatient 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. | Behavioural | Familiar Auditory Sensory Training |
| Sham Auditory Sensory TrainingThe 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. | Behavioural | Sham Auditory Sensory Training |
Primary outcome
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.
1 secondary outcome
Coma Near Coma Scale
Time frame: Baseline and after the 8th CNC assessment (4 weeks after Baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23341285Pape 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.
- Derived from this study: PubMed 25613986Pape 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa LB Pape, DrPH MA BS principal investigator
Edward Hines Jr. VA Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Familiar Auditory Sensory Training in people with Traumatic Brain Injury and Coma, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change (time frame: Baseline and immediately after treatment ends (6 weeks after Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00557076, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.