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

December 11, 2015 updated by: Rene L. Padilla, Creighton University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Persons in a coma or persistent vegetative state (Glasgow Coma Scale below 8) after traumatic brain injury

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glasgow Coma Scale
Time Frame: 0-30 days post injury
0-30 days post injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: Rene L Padilla, PhD, Creighton University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 14, 2015

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 11, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJOT/2015/021022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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