Unilateral Spatial Neglect (USN)NCT02919722
The Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect
A study testing Music Therapy in people with Unilateral Spatial Neglect (USN), run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unilateral Spatial Neglect (USN)
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 19 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Unilateral Spatial Neglect (USN)
- Being tested
- Music Therapy
- Keywords
- Music therapy, sensorimotor cortex, brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Spatial Neglect (USN)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Im, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919722
- Sponsor's protocol ID
- 16-00189
- Status last verified
- Aug 2020
- First submitted
- 28 Sep 2016
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect
- ClinicalTrials.gov ID
- NCT02919722
- Acronym / sponsor ID
- 16-00189
- Conditions
- Unilateral Spatial Neglect (USN)
- Keywords
- Music therapy, sensorimotor cortex, brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music interventions | Experimental | Behavioral: Music TherapyLive 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyThe 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. | Behavioural | Music interventions |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
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Evaluation of the Variation Over Time of Visuospatial Deficit in Patients With Parietal Lobe Glioma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Im, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Unilateral Spatial Neglect (USN), run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Star Cancellation Test and Picture Scanning Test (from the Behavioral Inattention Test (BIT) (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.