NCT00163878

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2004

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 4, 2006

Status Verified

August 1, 2005

First QC Date

September 12, 2005

Last Update Submit

October 3, 2006

Conditions

Traumatic Brain Injury

Keywords

Sensory Stimulation Programs

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Fucntional status at six months, assessed using the modified Barthel

Interventions

Sensory StimulationPROCEDURE
Sesnory Modality Assessment and Rehabilitation TechniqueDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

RECRUITING

The Alfred Hosptial

Melbourne, Victoria, 3181, Australia

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jacqui M Morarty, Occupational Therapist

    Bayside Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqui M Morarty, Occupational Therapist

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

November 1, 2004

Study Completion

December 1, 2006

Last Updated

October 4, 2006

Record last verified: 2005-08

Locations

AU(2)