Recruiting

Observational Study

Sponsor:

Temple University

Code:

NCT02959736

Conditions

Brain Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

MATADOC and CRS-R

Study Details

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

Study ID

NCT02959736

Start date

Dec, 2016

Status verified date

Sep, 2019

Completion date

Dec, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not 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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

National Rehabilitation Hospital Dublin

Music Therapy (MATADOC)

Spectrum

Music Therapy (MATADOC)

Royal Hospital for Neuro-disability London

Music Therapy (MATADOC)

Interventions

MATADOC and CRS-R

Behavioural assessments for Disorders of Consciousness

Primary outcome measure

  • Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) [ Time Frame: 16 days ]

Central Contacts and Locations

Central contacts

Wendy Magee, PhD

2152048314wmagee@temple.edu

Locations

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19122

Contacts

Wendy Magee

215-204-8314wmagee@temple.edu

Principal Investigator:

Erin Wegener, MM

More Information

Sponsor

Temple University

Last update posted

Sep 10, 2019

Last verified

Sep, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2019-09-10.