Evaluation of the MuSICCA for Measuring Awareness

NCT04050995 | Recruiting DMC

• 2 other identifiers: TCT 021167534
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Disorder of Consciousness

Outcome Measures

Primary Outcomes (2)

• Music therapy Sensory Instrument for Cognition, Consciousness and Awareness

  Measure of awareness

  2 weeks

• Coma Recovery Scale - Revised

  Diagnostic tool for disorders of consciousness

  1 day

Secondary Outcomes (2)

• Coma Near Coma Scale

  1 day

• Nociception Coma Scale

  1 day

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

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

Sponsors & Collaborators

• The Children's Trust, United Kingdom: lead
• Temple University: collaborator

Study Sites (3)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

Bethany Children's Health Centre

Bethany, Oklahoma, 73008, United States

RECRUITING

The Children's Trust

Tadworth, Surrey, KT20 5RU, United Kingdom

RECRUITING

Related Publications (1)

• Pool JW, Siegert RJ, Taylor S, Dunford C, Magee W. Evaluating the validity, reliability and clinical utility of the Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA): protocol of a validation study. BMJ Open. 2020 Aug 13;10(8):e039713. doi: 10.1136/bmjopen-2020-039713.

  PMID: 32792456 DERIVED

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jonathan W Pool, PhD

  Anglia Ruskin University

  STUDY DIRECTOR

Central Study Contacts

Jonathan W Pool, PhD

CONTACT

0044 (0)1223 695401; jonathan.pool1@aru.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 9, 2019
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

GB (1); US (2)