Evaluating a music therapy tool for measuring awareness in children with disorders of consciousness
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
This study is testing a new music therapy tool to see if it can help understand awareness in children with severe disorders of consciousness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | The Children's Trust, United Kingdom Academic / other |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT04050995 on ClinicalTrials.gov |
What this trial studies
This research evaluates the MuSICCA, a music therapy assessment tool designed for children with prolonged disorders of consciousness, such as the vegetative state and minimally conscious state. The study aims to assess the validity, reliability, and clinical utility of the MuSICCA by comparing its results to established measures like the Coma Recovery Scale-Revised. It will involve 80 participants aged 2-18 who have been assessed as having a disorder of consciousness. The study is observational and does not involve a control group, ensuring all participants receive the assessment measures.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-18 who have been assessed as having a disorder of consciousness.
Not a fit: Patients with known hearing impairments, profound visual impairments, or seizure disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for accurately diagnosing and assessing awareness in children with disorders of consciousness, leading to better care and treatment.
How similar studies have performed: Previous studies have successfully validated similar assessment tools for adults, but this approach for children is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Known hearing impairments * Known profound visual impairments * Known musicogenic epilepsy * Seizure disorders that cause frequent and/or prolonged seizures * English not first language
Where this trial is running
Atlanta, Georgia and 2 other locations
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Bethany Children's Health Centre — Bethany, Oklahoma, United States (Recruiting)
- The Children's Trust — Tadworth, Surrey, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jonathan W Pool, PhD
- Email: jonathan.pool1@aru.ac.uk
- Phone: 0044 (0)1223 695401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.