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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02919722
Other study ID # 16-00189
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date December 19, 2019

Study information

Verified date August 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 19, 2019
Est. primary completion date December 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Music Therapy
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.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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