Validating the MATADOC Against Best Practice Standard External Reference Standard

NCT ID: NCT02959736

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

National Rehabilitation Hospital Dublin

Music Therapy (MATADOC)

MATADOC and CRS-R

Intervention Type BEHAVIORAL

Behavioural assessments for Disorders of Consciousness

Spectrum

Music Therapy (MATADOC)

MATADOC and CRS-R

Intervention Type BEHAVIORAL

Behavioural assessments for Disorders of Consciousness

Royal Hospital for Neuro-disability London

Music Therapy (MATADOC)

MATADOC and CRS-R

Intervention Type BEHAVIORAL

Behavioural assessments for Disorders of Consciousness

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MATADOC and CRS-R

Behavioural assessments for Disorders of Consciousness

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Music Therapy and Coma Recovery Scale (Revised) or CRS-R

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Rehabilitation Hospital, Dublin, Ireland (NRH)

UNKNOWN

Sponsor Role collaborator

Royal Hospital for Neuro-disability

OTHER

Sponsor Role collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wendy Magee, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Temple University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wendy Magee, PhD

Role: CONTACT

2152048314

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wendy Magee

Role: primary

215-204-8314

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23925

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Brain Injury Neurorehabilitation Project
NCT06556316 ACTIVE_NOT_RECRUITING