Evaluation of the MuSICCA for Measuring Awareness

Recruiting now

Conditions studied: Disorder of Consciousness

In brief

Prolonged Disorders Of Consciousness (PDOC) include the Vegetative State (VS) and the Minimally Conscious State (MCS) that persist for longer than four weeks. This research seeks to evaluate the validity (accuracy), reliability, and clinical utility (usefulness to clinicians) of the children's version of the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC). The paediatric version is called the Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA). The MATADOC is known to be accurate in diagnosis and has been shown to be clinically useful when working with adults. However, currently, there are no equivalent measures that have been rigorously tested for working with children. Therefore, there is a significant need for a valid and reliable measure, especially when the consequences of misdiagnosis include insufficient care provision, unsuitable treatment programmes, poor identification of intentions to communicate, and insufficient evidence for making difficult decisions around withdrawal of hydration and nutrition. The study will invite participants aged 2-18 years, who the medical team suspect of having a PDOC, from various medical facilities in the UK, Ireland and other English-speaking countries. Parental/carer consent will be required for inclusion in the study. Data collection will occur over 3 years. Each participant will be involved once for a maximum of 7 assessment sessions (4 for the MuSICCA, 1 for the Coma Recovery Scale - Revised (CRS-R), 1 for the Coma/Near Coma Scale (CNC), and 1 for the Nociception Coma Scale Revised (NCS-R)). The MuSICCA assessment protocol involves presenting musical stimuli in three modalities (visual, auditory, and tactile). The participants will be instructed to respond to stimuli and commands. Sessions will be recorded using audio-visual equipment and physical responses will be noted on documentation. The information gained will inform diagnosis and treatment. The participants' behaviours will also be scored on the CRS-R (the gold standard for diagnosis of DOC in adults), the CNC and the NCS-R.

Key facts

Study ID

NCT04050995

Run by

The Children's Trust, United Kingdom

People needed

80

Starts

2022-04-01

Expected to finish

2027-12-01

Last updated by the study team

2025-04-30

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 2-18 years of age
• Assessed by the interdisciplinary team as having a disorder of consciousness
• Be under active investigation for diagnosis of DOC

You may not qualify if…

• Known hearing impairments
• Known profound visual impairments
• Known musicogenic epilepsy
• Seizure disorders that cause frequent and/or prolonged seizures
• English not first language

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Bethany Children's Health Centre — Bethany, Oklahoma, United States (enrolling)
• The Children's Trust — Tadworth, Surrey, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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