- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02919722
The Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect
August 17, 2020 updated by: NYU Langone Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music interventions
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Star Cancellation Test and Picture Scanning Test (from the Behavioral Inattention Test (BIT)
Time Frame: 1 Day
|
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)
Time Frame: 1 Day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Im, MD, New York University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
December 19, 2019
Study Completion (Actual)
December 19, 2019
Study Registration Dates
First Submitted
September 28, 2016
First Submitted That Met QC Criteria
September 28, 2016
First Posted (Estimate)
September 29, 2016
Study Record Updates
Last Update Posted (Actual)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 17, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-00189
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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