Effectiveness of Sensory Stimulation for Person in a Coma or Persistent Vegetative State After Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT02629588|
Recruitment Status : Completed
First Posted : December 14, 2015
Last Update Posted : December 14, 2015
|Condition or disease||Intervention/treatment|
|Brain Injuries||Behavioral: Multimodal or Unimodal Sensory stimulation|
Background: Traumatic brain injury (TBI) accounts for approximately 50,000 deaths in the United States each year. About 17% of survivors have a period of "coma". Duration of coma contributes significantly to functional outcomes.
Objective: To appraise the evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after TBI.
Data Sources and Study Eligibility Criteria: Databases searched included Medline, PsycINFO, CINAHL, OTseeker, and the Cochrane Database of Systematic Reviews. The search was limited to outcomes studies in the hierarchy described by Sackett and colleagues (1996), published in English in peer-reviewed journals between 2006 and 2014.
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||Effectiveness of Sensory Stimulation for Person in a Coma or Persistent Vegetative State After Traumatic Brain Injury|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Persons in coma or vegetative state
People who survived TBI have a period of complete unconsciousness or coma with no awareness of themselves or their surroundings received multimodal or unimodal sensory stimulation.People in a coma are unaware and unresponsive, but not asleep as there is no sleep-wake cycle. While in a coma, people are unable to speak, follow commands or open their eyes. The person in coma may have a simple reflex in response to touch or pain, but essentially there is no meaningful response to external stimuli. There is an absence of awareness of self and the environment, even under conditions of vigorous external stimulation. Coma can last from hours to days, depending on the severity of the brain damage, and sometimes a person can remain in a comatose state for months and even years.
Behavioral: Multimodal or Unimodal Sensory stimulation
multimodal sensory stimulation, unimodal sensory stimulation, auditory stimulation, complex stimulation, median nerve stimulation.
- Glasgow Coma Scale [ Time Frame: 0-30 days post injury ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629588
|Principal Investigator:||Rene L Padilla, PhD||Creighton University|