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

A Randomised Control Trial to Determine the Effectiveness of Sensory Stimulation Program in Reducing the Length of Time Spent by Severely Brain Injured Patients in a Vegetative State in the Acute Hospital Environment

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00163878
Enrollment
Unknown
Registered
2005-09-14
Start date
2004-11-30
Completion date
2006-12-31
Last updated
2006-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Sensory Stimulation Programs

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).

Detailed description

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 occupational therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART). The SMART is both an assessment and treatment too. Patients in both groups will have baseline assessments conducted using the SMART, with further assessments conducted every ten days for thrity days. The SMART is designed to provide quantitative data in the assessment of the patients cognitive function and potential awareness. It is a five point hierarchical scale from level 1 ( no response) to level 5 (discriminating).

Interventions

DEVICESesnory Modality Assessment and Rehabilitation Technique

Sponsors

Victorian Trauma Foundation
CollaboratorOTHER
Bayside Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Fucntional status at six months, assessed using the modified Barthel

Countries

Australia

Contacts

Primary ContactJacqui M Morarty, Occupational Therapist
j.morarty@alfred.org.au61 (0)3 92763526

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026