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

B

Bayside Health

Status and phase

Unknown
Phase 4

Conditions

Traumatic Brain Injury

Treatments

Device: Sesnory Modality Assessment and Rehabilitation Technique
Procedure: Sensory Stimulation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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).

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

2

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Central trial contact

Jacqui M Morarty, Occupational Therapist

Data sourced from clinicaltrials.gov

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