Validating the MATADOC Against Best Practice Standard External Reference Standard

Study Overview
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Brief Summary
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The purpose of this project is to further develop a standardized music-based measure used in music therapy with adults who have emerged from coma following profound brain injury, but are not able to demonstrate responsiveness to their environment due to complex clinical needs. Building on previous work, the project aims to strengthen the psychometric properties (e.g. concurrent validity, responsiveness) of the measure for its use with adults with profound brain damage.

Detailed Description
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Adult patients with prolonged disorders of consciousness (PDOC), but who have not been diagnosed as Minimally Conscious or Vegetative State, will be recruited. All participants will be assessed using the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) standardized protocol. Assessment intervention will take place in four individual clinical contacts, over a 16 day period. Data will be collected using the MATADOC rating form and scored according to the MATADOC manual. Participants will concurrently be assessed with Coma Recovery Scale-Revised (CRS-R). The MATADOC is implemented by Music Therapists who have been trained in its use and who are experienced in working with adults with PDOC. CRS-R data will be collected by members of the treatment team who are experienced or trained in its use. MATADOC and CRS-R assessors will remain blinded to the data collected. Analysis will compare diagnostic outcomes of the two measures as well as explore the function of comparable items of each measure across similar domains (e.g. auditory, visual).

Official Title
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Validating the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) Against the Best Practice External Reference Standard

Conditions
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Brain Injuries

Intervention / Treatment
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* Behavioral: MATADOC and CRS-R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically stable patients (i.e. not currently suspected of or under investigation for infection)who have a prolonged disorder of consciousness i.e. has persisted for longer than 4 weeks Between the ages of 18 and 70 years of age A diagnosis of awareness (i.e., VS, MCS or emergent) is not confirmed or is under investigation Fluent in English language comprehension as reported by the family Exclusion Criteria: Known pre-morbid hearing impairments The patient has a previous diagnosis of musicogenic epilepsy The patient had previously refused music therapy intervention Patients with a suspected diagnosis of locked-in syndrome Non-fluent in English comprehension as reported by family.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| National Rehabilitation Hospital Dublin<br>Music Therapy (MATADOC) | Behavioral: MATADOC and CRS-R<br>* Behavioural assessments for Disorders of Consciousness<br>* Other names: Music Therapy and Coma Recovery Scale (Revised) or CRS-R;|
| Spectrum<br>Music Therapy (MATADOC) | Behavioral: MATADOC and CRS-R<br>* Behavioural assessments for Disorders of Consciousness<br>* Other names: Music Therapy and Coma Recovery Scale (Revised) or CRS-R;|
| Royal Hospital for Neuro-disability London<br>Music Therapy (MATADOC) | Behavioral: MATADOC and CRS-R<br>* Behavioural assessments for Disorders of Consciousness<br>* Other names: Music Therapy and Coma Recovery Scale (Revised) or CRS-R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) | Music based protocol | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coma Recovery Scale - Revised (CRS-R) | Behavioural rating scale | 16 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vegetative State (VS), Minimally Conscious State (MCS), Brain Injuries