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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
Sponsor:
Information provided by (Responsible Party):
Rene L. Padilla, Creighton University

Brief Summary:
Appraised the empirical evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after traumatic brain injury (TBI). Databases were searched and nine articles met inclusion criteria.

Condition or disease Intervention/treatment
Brain Injuries Behavioral: Multimodal or Unimodal Sensory stimulation

Detailed Description:

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
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Glasgow Coma Scale [ Time Frame: 0-30 days post injury ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Persons in a coma or persistent vegetative state (Glasgow Coma Scale below 8) after traumatic brain injury
Criteria

Inclusion Criteria:

  • in coma or persistent vegetative state after traumatic brain injury

Exclusion Criteria:

  • coma or persistent vegetative state not caused by traumatic brain injury

Information from the National Library of Medicine

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


Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Rene L Padilla, PhD Creighton University

Additional Information:
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rene L. Padilla, Associate Professor of Occupational Therapy, Creighton University
ClinicalTrials.gov Identifier: NCT02629588     History of Changes
Other Study ID Numbers: AJOT/2015/021022
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rene L. Padilla, Creighton University:
Coma
Persistent Vegetative State
Sensory Stimulation

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Persistent Vegetative State
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms