Back to resultsThe Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect
Primary Purpose
Unilateral Spatial Neglect (USN)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Spatial Neglect (USN) focused on measuring Music therapy, sensorimotor cortex, brain injury
Eligibility Criteria
Inclusion Criteria:
- 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.
- The KF-NAP, which is administered to all patients with suspected neglect on admission, will be used as a screening tool for the neglect syndrome. Inclusion criteria will be participants with score of ≤ 5.
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music interventions
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02919722
Brief Title
The Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect
Official Title
The Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
An open, single group of ten patients selected will receive a 30 minute music therapy/occupational therapy co-treatment intervention. Music interventions will be performed by a licensed, Board-Certified Music Therapist while a licensed Occupational Therapist will provide support, assistance, and measurements of behavioral attention/inattention. At the outset of the first session patients will be briefly, informally interviewed to ascertain their musical preferences, which will then be integrated into the music therapist's interventions whenever possible to maximize engagement and therapeutic rapport. 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. An outcome measurement tool (Star Cancellation Test) will be focused on measuring hemispheric neglect and administered at the beginning and end of each session to measure within session changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Spatial Neglect (USN)
Keywords
Music therapy, sensorimotor cortex, brain injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music interventions
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Star Cancellation Test and Picture Scanning Test (from the Behavioral Inattention Test (BIT)
Description
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.
Time Frame
1 Day
Title
Picture Scanning Test (PST)
Description
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.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
The KF-NAP, which is administered to all patients with suspected neglect on admission, will be used as a screening tool for the neglect syndrome. Inclusion criteria will be participants with score of ≤ 5.
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Im, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect
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