NCT02919722

Brief Summary

Investigators hypothesize, based on anecdotal evidence to date, that active music making interventions conducted on a patient's neglected side will result in improved attention to that side and that this will be measurable within session.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2019

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

3.3 years

First QC Date

September 28, 2016

Last Update Submit

August 17, 2020

Conditions

Keywords

Music therapysensorimotor cortexbrain injury

Outcome Measures

Primary Outcomes (2)

  • Star Cancellation Test and Picture Scanning Test (from the Behavioral Inattention Test (BIT)

    54 targets dispersed amongst 75 distractors. Patients are asked to cross out all of the small stars within the field, placed at midline, using a pen.

    1 Day

  • Picture Scanning Test (PST)

    3 large color photos that depict: (1) a meal on a dish, (2) a wash basin and toiletries, (3) a large window flanked by sundry objects. Participant is asked to name and point to the main items see in the picture.

    1 Day

Study Arms (1)

Music interventions

EXPERIMENTAL

Live music will be provided on the patient's neglected side and patients will be encouraged to play music interactively with a focus towards that side whenever possible

Behavioral: Music Therapy

Interventions

Music TherapyBEHAVIORAL

The majority of each study session will be spent engaging in music therapy: playing live music with a music therapist with the help of an occupational therapist. At the beginning and end of each session subjects will complete 2 assessments.

Music interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients experiencing unilateral left spatial neglect post brain injury (stroke, TBI, N-TBI).
  • Patients able to follow two step commands and maintain attention to task for five minutes in a quiet environment.
  • Patients must be able to hold a pencil to complete the SCT
  • Patients must be able to discriminate between distractor items (words versus big and small stars) and see items in picture cards
  • Patients communicate willingness to participate in music therapy interventions.
  • Admission to acute inpatient rehabilitation unit at NYU/HJD.
  • Patient will have the ability to provide informed consent.

You may not qualify if:

  • Visual impairment.
  • Right side or dominant hand impairment.
  • Any social or medical problem that precludes completion of the protocol.
  • Patients who have sensory neglect or motor neglect , as the SCT cannot be used with this population
  • Severe language comprehension impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Brian Im, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

September 29, 2016

Study Start

September 1, 2016

Primary Completion

December 19, 2019

Study Completion

December 19, 2019

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations