Effectiveness of Sensory Stimulation for Person in a Coma or Persistent Vegetative State After Traumatic Brain Injury

Completed

• Conditions: Brain Injuries
• Interventions: Behavioral: Multimodal or Unimodal Sensory stimulation

• Registration Number: NCT02629588
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-12
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-11
• Last Update Submitted: 2015-12-11
• Study First Posted: 2015-12-14
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persons in coma or vegetative state	Multimodal or Unimodal Sensory stimulation	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.

Primary Outcome Measures

Name	Time	Method
Glasgow Coma Scale	0-30 days post injury