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Status unknownNCT02959736MATADOCUpdated Sep 10, 2019

Validating the MATADOC Against Best Practice Standard External Reference Standard

An observational study in Brain Injuries, sponsored by Temple University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-10.

Sponsored by Temple University · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Brain Injuries

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Keywords

  • Vegetative State (VS)
  • Minimally Conscious State (MCS)
  • Brain Injuries
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 80 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • National Rehabilitation Hospital Dublin

    Music Therapy (MATADOC)

    Behavioral: MATADOC and CRS-R

  • Spectrum

    Music Therapy (MATADOC)

    Behavioral: MATADOC and CRS-R

  • Royal Hospital for Neuro-disability London

    Music Therapy (MATADOC)

    Behavioral: MATADOC and CRS-R

Interventions

  • BehavioralMATADOC and CRS-R

    Behavioural assessments for Disorders of Consciousness

    Also known as: Music Therapy and Coma Recovery Scale (Revised) or CRS-R

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What researchers measure

Primary outcomes

  1. Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC)

    Music based protocol

    Time frame: 16 days

Secondary outcomes

  1. Coma Recovery Scale - Revised (CRS-R)

    Behavioural rating scale

    Time frame: 16 days

07

Study locations

1 of 1 sites recruiting
  • Temple University
    Philadelphia, Pennsylvania 19122, United States
    • Wendy Magee · Contact · wmagee@temple.edu · 215-204-8314
    • Erin Wegener, MM · Principal investigator
    • Kudret Yelden, MD · Principal investigator
    • Mark Delargy, BA BCh BAO · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02959736
Lead sponsor
Temple University
Collaborators
National Rehabilitation Hospital, Dublin, Ireland (NRH), Royal Hospital for Neuro-disability, Spectrum Health Hospitals
Responsible party
Sponsor
First posted
Nov 9, 2016
Start date
Dec 2016
Primary completion
Jun 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Sep 10, 2019

Study contacts

Wendy Magee, PhD
Contact
wmagee@temple.edu
2152048314
Wendy Magee, PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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