Disorder of ConsciousnessNCT04050995
Evaluation of the MuSICCA for Measuring Awareness
An observational study of Disorder of Consciousness, run by The Children's Trust, United Kingdom at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Disorder of Consciousness
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Apr 2022to 1 Dec 2027
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Known hearing impairments
- Known profound visual impairments
- Known musicogenic epilepsy
- Seizure disorders that cause frequent and/or prolonged seizures
- English not first language
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Cori Snyder, cori.snyder@choa.org
- Recruiting
Bethany Children's Health Centre
Bethany, Oklahoma, 73008
Rachel nowels, rnowels@bethanychildrens.org
United Kingdom1 site, 1 recruiting
- Recruiting
The Children's Trust
Tadworth, Surrey, KT20 5RU
Helle Mills, hmills@thechildrenstrust.org.uk
About this study
Official title: Evaluating the Validity, Reliability, and Clinical Utility of the Music Therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA) in Children and Youth With Prolonged Disorders of Consciousness
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.
Read the detailed description
The null hypotheses are as follows:
The MuSICCA is not a valid tool for use with children and young people with Disorders Of Consciousness (DOC).
The MuSICCA is not a reliable tool for use with children and young people with DOC.
The MuSICCA is not a clinical useful tool for use with children and young people with DOC.
The design has been chosen to test the validity and reliability of the MuSICCA. It will involve carrying out the two measures and comparing their results against the current gold standard (the Coma Recovery Scale-Revised) and the Coma-Near Coma Scale. The design is influenced by previous validation studies of these measures conducted with adults.
There will be no control group because this is not a Randomised Controlled Trial (RCT) and, therefore, no recruited participant will be deprived of the potential benefits of the measures. All participants will receive intervention through the administration of the protocols of the assessment measures.
The study intends to recruit 80 participants. Recruitment will involve the following procedure. Medical/clinical teams at each site will identify potential participants according to the inclusion and exclusion criteria. The participants' families will be contacted to invite them to a meeting to discuss the research. It will be made clear that there will be no obligation to attend the meeting and their care or treatment will not be reduced or withdrawn if they decide not to be involved in the study. Interested families will be informed about the research project at this initial meeting. This information will be delivered verbally in person by the assessing clinicians and the families will be given a participant information sheet, which will contain all the information about the research so that the family can think in their own time about the decision to involve their child. The information given will include: 1)what will be carried out during the assessments, 2)how data will be recorded (observation recording sheets, video recording), 3)how the data will be stored, 4)what the data will be used for, and 5)what will be done with the data when the study has finished. The information sheet will also contain information about the families' right to withdraw their child from the study at any time without consequence.
The families will also be given the opportunity to ask questions so that they are satisfied that they understand why the research is being conducted, what the research will involve, and the extent of their child's involvement in the study if recruited.
Data collection will take place over a 3-year period at sites in the United Kingdom (UK), United States, and other English-speaking countries, e.g. Australia, Canada and New Zealand.
The data will consist of hand scored forms of the assessment tools and audio-visual recordings of the MuSICCA sessions. These recordings will be used to test the reliability of the MuSICCA between assessors and between assessment sessions.The selection and allocation of video recordings of sessions for inter-rater reliability will be carried out to control for differences of experience between assessing clinicians.
In order to eliminate researcher bias, data will be collated by the trained assessors from the treating clinical team, and statistical analysis will be undertaken by an independent statistician. In order to eliminate bias during data collection, there will be no interim data analysis and data collectors (clinicians) will not be able to discuss with each other the findings of their assessments until after the assessments have been completed and the results submitted to the research assistant.
Clinical utility of the MuSICCA will be evaluated using a questionnaire for each family and each assessing clinician using the tool. After each MuSICCA report is submitted and feedback given to the families, assessing clinicians and families will be asked to complete a short questionnaire to assess the clinical utility of the MuSICCA.
Data storage Raw data (score forms and video recordings) will be stored on a secure cloud-based system. Access to the data will be managed and authorised by the Chief Investigator.
Data analysis will be carried out by an independent statistician.
- Conditions
- Disorder of Consciousness
- Medical subject headings
- Consciousness Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Music therapy Sensory Instrument for Cognition, Consciousness and Awareness
Measure of awareness
Measured: 2 weeks
Coma Recovery Scale - Revised
Diagnostic tool for disorders of consciousness
Measured: 1 day
Secondary outcomes (2)
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
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Apr 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- The Children's Trust, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University
- Responsible party
- Sponsor
- Investigators
- Jonathan W Pool, PhD, Study director, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050995
- Sponsor's protocol ID
- TCT 021
- Other IDs
- 167534
- Status last verified
- Apr 2025
- First submitted
- 7 Aug 2019
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Following completion of the study, de-identified, anonymised data (with participant consent) will be available from the corresponding author. Data made available will include individual-level de-identified, anonymised participant data, excluding audio-visual recordings from the MuSICCA sessions.
Publications
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.
PubMed 32792456
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Validity, Reliability, and Clinical Utility of the Music Therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA) in Children and Youth With Prolonged Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT04050995
- Acronym / sponsor ID
- TCT 021
- Conditions
- Disorder of Consciousness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Children's Trust, United KingdomUniversity, hospital or other
- Collaborators
- Temple University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The null hypotheses are as follows:
The MuSICCA is not a valid tool for use with children and young people with Disorders Of Consciousness (DOC).
The MuSICCA is not a reliable tool for use with children and young people with DOC.
The MuSICCA is not a clinical useful tool for use with children and young people with DOC.
The design has been chosen to test the validity and reliability of the MuSICCA. It will involve carrying out the two measures and comparing their results against the current gold standard (the Coma Recovery Scale-Revised) and the Coma-Near Coma Scale. The design is influenced by previous validation studies of these measures conducted with adults.
There will be no control group because this is not a Randomised Controlled Trial (RCT) and, therefore, no recruited participant will be deprived of the potential benefits of the measures. All participants will receive intervention through the administration of the protocols of the assessment measures.
The study intends to recruit 80 participants. Recruitment will involve the following procedure. Medical/clinical teams at each site will identify potential participants according to the inclusion and exclusion criteria. The participants' families will be contacted to invite them to a meeting to discuss the research. It will be made clear that there will be no obligation to attend the meeting and their care or treatment will not be reduced or withdrawn if they decide not to be involved in the study. Interested families will be informed about the research project at this initial meeting. This information will be delivered verbally in person by the assessing clinicians and the families will be given a participant information sheet, which will contain all the information about the research so that the family can think in their own time about the decision to involve their child. The information given will include: 1)what will be carried out during the assessments, 2)how data will be recorded (observation recording sheets, video recording), 3)how the data will be stored, 4)what the data will be used for, and 5)what will be done with the data when the study has finished. The information sheet will also contain information about the families' right to withdraw their child from the study at any time without consequence.
The families will also be given the opportunity to ask questions so that they are satisfied that they understand why the research is being conducted, what the research will involve, and the extent of their child's involvement in the study if recruited.
Data collection will take place over a 3-year period at sites in the United Kingdom (UK), United States, and other English-speaking countries, e.g. Australia, Canada and New Zealand.
The data will consist of hand scored forms of the assessment tools and audio-visual recordings of the MuSICCA sessions. These recordings will be used to test the reliability of the MuSICCA between assessors and between assessment sessions.The selection and allocation of video recordings of sessions for inter-rater reliability will be carried out to control for differences of experience between assessing clinicians.
In order to eliminate researcher bias, data will be collated by the trained assessors from the treating clinical team, and statistical analysis will be undertaken by an independent statistician. In order to eliminate bias during data collection, there will be no interim data analysis and data collectors (clinicians) will not be able to discuss with each other the findings of their assessments until after the assessments have been completed and the results submitted to the research assistant.
Clinical utility of the MuSICCA will be evaluated using a questionnaire for each family and each assessing clinician using the tool. After each MuSICCA report is submitted and feedback given to the families, assessing clinicians and families will be asked to complete a short questionnaire to assess the clinical utility of the MuSICCA.
Data storage Raw data (score forms and video recordings) will be stored on a secure cloud-based system. Access to the data will be managed and authorised by the Chief Investigator.
Data analysis will be carried out by an independent statistician.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Known hearing impairments
- Known profound visual impairments
- Known musicogenic epilepsy
- Seizure disorders that cause frequent and/or prolonged seizures
- English not first language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Music therapy Sensory Instrument for Cognition, Consciousness and Awareness
Time frame: 2 weeks
Measure of awareness
Coma Recovery Scale - Revised
Time frame: 1 day
Diagnostic tool for disorders of consciousness
2 secondary outcomes
Coma Near Coma Scale
Time frame: 1 day
Nociception Coma Scale
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 32792456Pool 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.
- Individual participant dataSharing planned: Undecided. Following completion of the study, de-identified, anonymised data (with participant consent) will be available from the corresponding author. Data made available will include individual-level de-identified, anonymised participant data, excluding audio-visual recordings from the MuSICCA sessions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan W Pool, PhD study director
Anglia Ruskin University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Consciousness, run by The Children's Trust, United Kingdom at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan W Pool, PhD (0044 (0)1223 695401 ext. 5401, jonathan.pool1@aru.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04050995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.