![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
Department of Veterans Affairs Rehabilitation Institute of Chicago Northwestern Memorial Hospital Feinberg School of Medicine, Northwestern University |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00557076 |
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 low-dose of FVs (Low Dose Group) and/or unconscious persons receiving SR and sham stimulation (Sham Group) will demonstrate:
Condition | Intervention | Phase |
---|---|---|
Traumatic Brain Injury Coma Vegetative State Minimally Conscious State |
Behavioral: Familiar Voice Stimulation High Dose Behavioral: Familiar Voice Stimulation Low Dose Behavioral: Sham Auditory Stimulation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Can Neural Adaptation After Severe Brain Injury be Facilitated? |
Estimated Enrollment: | 45 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
high dose of familiar voice stimulation
|
Behavioral: Familiar Voice Stimulation High Dose
The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs.
|
2: Active Comparator
low dose of familiar voice stimulaiton
|
Behavioral: Familiar Voice Stimulation Low Dose
The Low Dose intervention is 210 minutes of Familiar Voice Stimulation is provided in 5 minute daily segments for 6 weeks. One CD with 5 minutes of Familiar Voice Stimulation preceded by the familiar voice calling out the Subject's name then followed by a recording of silence for 5 minutes will be played 1 time each day for 6 weeks. Three other CDs with 10 minutes of silence recorded on each CD will also be played 1 time per day for 6 weeks.
|
3: Sham Comparator
sham auditory stimulaiton
|
Behavioral: Sham Auditory Stimulation
The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulatin will b e provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence.
|
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:
There are three study cohorts and each group receives standard rehabilitation. The experimental group or High-Dose Group will, in addition to standard rehabilitation, be exposed daily to 40 minutes of FVs for 6 weeks. The Low-Dose Group (Control Group 1) will receive standard rehabilitation plus 5 minutes of FVs and 35 minutes of sham treatment daily for 6 weeks. The Sham Group (Control Group 2) will receive standard rehabilitation plus 40 minutes of sham treatment daily for 6 weeks.
The 40 minutes of FVs treatment will be provided in four 10 minutes 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ann Guernon, MS | (630) 909-7146 | aguernon@marianjoy.org |
Contact: Cheryl C Odle, MBA | (708) 202-8387 ext 23117 | cheryl.odle@va.gov |
United States, Illinois | |
Edward Hines, Jr. VA Hospital | Recruiting |
Hines, Illinois, United States, 60141-3030 | |
Contact: Ann Guernon, MS 630-909-7146 aguernon@marianjoy.org | |
Contact: Cheryl C Odle, MBA (708) 202-8387 ext 23117 cheryl.odle@va.gov | |
Principal Investigator: Theresa Louise-Bender Pape, BS MA DrPH | |
The Rehabilitation Institute of Chicago | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Julie Fuith, MS 312-238-1900 jfuith@ric.org | |
United States, Virginia | |
Hunter Holmes McGuire VA Medical Center | Recruiting |
Richmond, Virginia, United States, 23249 | |
Contact: Shane Mcnamee, MD 804-675-5117 shane.mcnamee@va.gov |
Principal Investigator: | Theresa Louise-Bender Pape, BS MA DrPH | Edward Hines Jr. VA Hospital |
Responsible Party: | Department of Veterans Affairs ( Pape, Theresa - Principal Investigator ) |
Study ID Numbers: | B4951R |
Study First Received: | November 8, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00557076 History of Changes |
Health Authority: | United States: Federal Government |
Randomized Clinical Trial Auditory Stimulation |
Persistent Vegetative State Craniocerebral Trauma Unconsciousness Brain Damage, Chronic Consciousness Disorders Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Brain Diseases Coma Signs and Symptoms Neurologic Manifestations Brain Injuries Neurobehavioral Manifestations |
Persistent Vegetative State Craniocerebral Trauma Unconsciousness Brain Damage, Chronic Consciousness Disorders Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Trauma, Nervous System Brain Diseases Coma Signs and Symptoms Neurologic Manifestations Brain Injuries Neurobehavioral Manifestations |