Validating the MATADOC Against Best Practice Standard External Reference Standard (MATADOC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Brain Injuries
• Intervention / Treatment: Behavioral: MATADOC and CRS-R

Detailed Description

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).

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Wendy Magee, PhD; Phone Number: 2152048314; Email: wmagee@temple.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Recruiting
      • Temple University
      • Contact: Wendy Magee; Phone Number: 215-204-8314; Email: wmagee@temple.edu
      • Principal Investigator: Erin Wegener, MM
      • Principal Investigator: Kudret Yelden, MD
      • Principal Investigator: Mark Delargy, BA BCh BAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults who have acquired profound brain damage resulting in prolonged disorders of consciousness (PDOC).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
National Rehabilitation Hospital Dublin; Music Therapy (MATADOC)	Behavioral: MATADOC and CRS-R; Behavioural assessments for Disorders of Consciousness; Other Names: Music Therapy and Coma Recovery Scale (Revised) or CRS-R
Spectrum; Music Therapy (MATADOC)	Behavioral: MATADOC and CRS-R; Behavioural assessments for Disorders of Consciousness; Other Names: Music Therapy and Coma Recovery Scale (Revised) or CRS-R
Royal Hospital for Neuro-disability London; Music Therapy (MATADOC)	Behavioral: MATADOC and CRS-R; Behavioural assessments for Disorders of Consciousness; Other Names: Music Therapy and Coma Recovery Scale (Revised) or CRS-R

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Spectrum Health Hospitals; National Rehabilitation Hospital, Dublin, Ireland (NRH); Royal Hospital for Neuro-disability, London, UK (RHN)
• Investigators: Principal Investigator: Wendy Magee, PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Brain Injuries; Vegetative State (VS); Minimally Conscious State (MCS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 23925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No