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NCT04050995 · ClinicalTrials.gov registry record
Evaluation of the MuSICCA for Measuring Awareness
A clinical trial of Disorder of Consciousness, sponsored by The Children's Trust, United Kingdom.
- Recruiting
- Registry status
- 80
- Enrollment target
- 3
- Study locations
NCT04050995: Recruiting study of Disorder of Consciousness, sponsored by The Children's Trust, United Kingdom.
NCT04050995 is a study of Disorder of Consciousness that is actively recruiting participants, run by The Children's Trust, United Kingdom. The registered enrollment target is 80 participants. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04050995, a study of Disorder of Consciousness, is actively recruiting participants, sponsored by The Children's Trust, United Kingdom.
- RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 3
- Study locations
Study 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
Primary Outcome
Measure of awareness
Conditions Studied
Study Locations (3)
Georgia
- Children's Healthcare of Atlanta - Atlanta
Oklahoma
- Bethany Children's Health Centre - Bethany
Surrey
- The Children's Trust - Tadworth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2027-12-01 |
What NCT04050995 shows while recruiting
NCT04050995 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 1 condition, with Disorder of Consciousness appearing as the primary indexed condition, and to 0 interventions.
NCT04050995 reports a single indexed study location in Georgia, Oklahoma, Surrey.
Frequently Asked Questions
What is clinical trial NCT04050995 about?
NCT04050995 is a clinical study titled "Evaluation of the MuSICCA for Measuring Awareness". 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 versi...
What is the current status of trial NCT04050995?
This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2022-04-01. Estimated completion is 2027-12-01.
What conditions does trial NCT04050995 study?
This clinical trial studies the following conditions: Disorder of Consciousness.
Who is sponsoring clinical trial NCT04050995?
This trial is sponsored by The Children's Trust, United Kingdom, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04050995 being conducted?
This trial has 3 study locations across Georgia, Oklahoma, Surrey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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