UnknownPhase 4

Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State

AustraliaStarted 2004-11

Plain-language summary

A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state. The experimental group would receive, in addition to their normal occuaptional therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART).

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * admitted with severe brain injury * GCS of 9 or less. A GCS score of 9 or less is indicative of a severe brain injury * medically stable, as documented by medical staff * age 18 to 65 years * controlled intracranial pressure no sedation * no previous brain injury Exclusion Criteria * patient declared brain dead * next of kin withdraws patient from the study * withdrawal of consent by patient on waking * raised uncontrolled intracranial pressure, following discussions with treating medical team * patient enrolled in DECRA or RSI Trials

What they're measuring

Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups

Trial details

NCT IDNCT00163878

SponsorBayside Health

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Contact for this trial

Jacqui M Morarty, Occupational Therapist

61 (0)3 92763526 j.morarty@alfred.org.au

View on ClinicalTrials.gov More Traumatic Brain Injury trials