MedDataX Logo

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

NCT ID: NCT00163878

Last Updated: 2006-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Sensory Stimulation Programs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sensory Stimulation

Intervention Type PROCEDURE

Sesnory Modality Assessment and Rehabilitation Technique

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Victorian Trauma Foundation

OTHER

Sponsor Role collaborator

Bayside Health

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jacqui M Morarty, Occupational Therapist

Role: PRINCIPAL_INVESTIGATOR

Bayside Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

The Alfred Hosptial

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jacqui M Morarty, Occupational Therapist

Role: CONTACT

Phone: 61 (0)3 92763526

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jacqui M Morarty, Occupational Therapist

Role: primary

Jacqui M Morarty, Occupational Therapist

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4468

Identifier Type: -

Identifier Source: org_study_id