Validating the MATADOC Against Best Practice Standard External Reference Standard

NCT02959736 | Unknown

• 1 other identifier: 23925
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Injuries

Keywords

Vegetative State (VS); Minimally Conscious State (MCS); Brain Injuries

Outcome Measures

Primary Outcomes (1)

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

  Music based protocol

  16 days

Secondary Outcomes (1)

• Coma Recovery Scale - Revised (CRS-R)

  16 days

Study Arms (3)

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

MATADOC and CRS-R BEHAVIORAL

Behavioural assessments for Disorders of Consciousness

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

National Rehabilitation Hospital Dublin; Royal Hospital for Neuro-disability London; Spectrum

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead
• National Rehabilitation Hospital, Dublin, Ireland (NRH): collaborator
• Royal Hospital for Neuro-disability: collaborator
• Corewell Health West: collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Persistent Vegetative State

Interventions

Music Therapy; Reoperation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Surgical Procedures, Operative

Study Officials

• Wendy Magee, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Magee, PhD

CONTACT

2152048314; wmagee@temple.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)