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Completed

NCT Number: NCT02629588

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

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.

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Key information

Conditions

Brain Injuries Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Craniocerebral Trauma Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Trauma, Nervous System Unconsciousness Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal or Unimodal Sensory stimulation

Behavioral

multimodal sensory stimulation, unimodal sensory stimulation, auditory stimulation, complex stimulation, median nerve stimulation.

Primary outcomes

  1. Glasgow Coma Scale

    Time frame: 0-30 days post injury

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 14, 2015
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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