Brain InjuriesMATADOCNCT02959736
Validating the MATADOC Against Best Practice Standard External Reference Standard
An observational study of Brain Injuries, run by Temple University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- MATADOC and CRS-R
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who have acquired profound brain damage resulting in prolonged disorders of consciousness (PDOC).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19122
Wendy Magee, 215-204-8314, wmagee@temple.edu
Erin Wegener, MM
About this study
Official title: 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.
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).
- Conditions
- Brain Injuries
- Being tested
- MATADOC and CRS-R
- Keywords
- Vegetative State (VS), Minimally Conscious State (MCS), Brain Injuries
- Medical subject headings
- Brain Injuries, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATADOC and CRS-RBehavioural
Also called Music Therapy and Coma Recovery Scale (Revised) or CRS-R
Behavioural assessments for Disorders of Consciousness
| Study group | Role | What they receive |
|---|---|---|
| National Rehabilitation Hospital Dublin | Music Therapy (MATADOC) Receives: Behavioral: MATADOC and CRS-R | |
| Spectrum | Music Therapy (MATADOC) Receives: Behavioral: MATADOC and CRS-R | |
| Royal Hospital for Neuro-disability London | Music Therapy (MATADOC) Receives: Behavioral: MATADOC and CRS-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC)
Music based protocol
Measured: 16 days
Secondary outcomes (1)
Coma Recovery Scale - Revised (CRS-R)
Behavioural rating scale
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Rehabilitation Hospital, Dublin, Ireland (NRH), Royal Hospital for Neuro-disability, Corewell Health West
- Responsible party
- Sponsor
- Investigators
- Wendy Magee, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959736
- Sponsor's protocol ID
- 23925
- Acronym
- MATADOC
- Status last verified
- Sep 2019
- First submitted
- 7 Nov 2016
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) Against the Best Practice External Reference Standard
- ClinicalTrials.gov ID
- NCT02959736
- Acronym / sponsor ID
- MATADOC / 23925
- Conditions
- Brain Injuries
- Keywords
- Vegetative State (VS), Minimally Conscious State (MCS), Brain Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Rehabilitation Hospital, Dublin, Ireland (NRH), Royal Hospital for Neuro-disability, Corewell Health West
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| National Rehabilitation Hospital Dublin | – | Behavioral: MATADOC and CRS-RMusic Therapy (MATADOC) |
| Spectrum | – | Behavioral: MATADOC and CRS-RMusic Therapy (MATADOC) |
| Royal Hospital for Neuro-disability London | – | Behavioral: MATADOC and CRS-RMusic Therapy (MATADOC) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have acquired profound brain damage resulting in prolonged disorders of consciousness (PDOC).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MATADOC and CRS-RAlso: Music Therapy and Coma Recovery Scale (Revised) or CRS-RBehavioural assessments for Disorders of Consciousness | Behavioural | National Rehabilitation Hospital Dublin, Royal Hospital for Neuro-disability London, Spectrum |
Primary outcome
Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC)
Time frame: 16 days
Music based protocol
1 secondary outcome
Coma Recovery Scale - Revised (CRS-R)
Time frame: 16 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Magee, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy Magee, PhD (2152048314, wmagee@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) (time frame: 16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019; AzTrials last refreshed its copy on 29 Oct 2026.