Validating the MATADOC Against Best Practice Standard External Reference Standard

Brain Injuries Clinical Trial

— MATADOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959736
• Other study ID #: 23925
• Status: Recruiting
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Temple University
• Contact: Wendy Magee, PhD
• Phone: 2152048314
• Email: wmagee[@]temple.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Behavioral:
• MATADOC and CRS-R
Behavioural assessments for Disorders of Consciousness

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Temple University	National Rehabilitation Hospital, Dublin, Ireland (NRH), Royal Hospital for Neuro-disability, London, UK (RHN), Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC)	Music based protocol	16 days
Secondary	Coma Recovery Scale - Revised (CRS-R)	Behavioural rating scale	16 days