About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known hearing impairments
Known profound visual impairments
Known musicogenic epilepsy
Seizure disorders that cause frequent and/or prolonged seizures
Trial population
Children and young people aged 2-18 years with a suspected disorder of consciousness. They will be identified by the treating clinical team initially.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Music therapy Sensory Instrument for Cognition, Consciousness and Awareness
Measure of awareness
Coma Recovery Scale - Revised
Diagnostic tool for disorders of consciousness
Secondary outcomes
Coma Near Coma Scale
Diagnostic tool for disorders of consciousness. Measuring wakefulness and awareness using sensory stimulation and ratings form responses. It is a scale comprised of 11 items with ratings for responses (0, 2, 4; 0 representing higher level response and 4 representing no response). The total score is calculated by adding the ratings and dividing by the number of items scored. Lower numbers indicate greater awareness/consciousness. The ranges are as follows: * 0.00-0.89 indicates NO COMA * 0.90-2.00 indicates NEAR COMA * 2.01-2.89 indicates MODERATE COMA * 2.90-3.49 indicates MARKED COMA * 3.50-4.00 indicates EXTREME COMA
Nociception Coma Scale
Assessment tool for measuring responses to potentially painful care and/or stimulation of a potentially painful area. It is a scale comprised of 3 items (motor response, verbal response, and facial expression). Ratings consist of 0, 1, 2, 3, with higher ratings indicating higher level responses.The total score is calculated summing the subscores. The total score range is 0-9. A total score equal to or above 4 suggests the presence of pain.
Sponsors and contacts
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The Children's Trust, United Kingdom
Lead sponsor
Temple University
Collaborator