Hemispatial NeglectNCT03516825
Musical Neglect Training for Patients With Visual Neglect
A study testing Musical Neglect Training in people with Hemispatial Neglect, run by University of Toronto.
Trial summary
Music Neglect Training has been developed for patients with hemispatial neglect to improve their attention on the left side. The purpose of this study was to examine the immediate and carry-over effect of Musical Neglect Training on unilateral visual neglect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemispatial Neglect
- What is being tested?
- Musical Neglect Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2015to 28 Jan 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with visual neglect after stroke
- right-handed
- medically stable
- no previous music therapy experiences
- no hearing impairments
- no cognitive deficits
Who cannot join
- hemianopia
- previous music therapy treatment experiences
About this study
Official title: Musical Neglect Training for Unilateral Visual Neglect in Right Hemispheric Stroke Patients
Music Neglect Training has been developed for patients with hemispatial neglect to improve their attention on the left side. The purpose of this study was to examine the immediate and carry-over effect of Musical Neglect Training on unilateral visual neglect. Standardized assessments (Albert's test and Line Bisection Test) were used to measure a range of visual field. A total of 6 musical exercises with tone bars which are aligned horizontally helped to improve attention and perception of the visual field on the left side.
Read the detailed description
Unilateral visual neglect from right hemisphere stroke is a condition that reduces a person's ability to attend to and process stimuli in one half, mostly left side, of their environment. This perceptual processing deficit can negatively affect individuals' daily living which in turn reduces functional independence. Music has been used as a therapeutic tool in a variety of settings to promote cognitive functions. In particular, music has been used to improve attention in the left sides for patients with visual neglect. Musical Neglect Training (MNT) has been developed for patients with visual neglect to improve attention in the left side.
The purpose of this study was to examine the immediate and longer-lasting effect of Musical Neglect Training (MNT) on unilateral visual neglect. A single-subject design was used, as participants served as their own control. Two individuals participated in this study. Participants underwent six individual MNT sessions. MNT uses musical exercises which are structured in pitch, time and tempo, and musical equipment (tone bars, keyboards, drums) configures to focus attention to the neglect visual field. Two standardized assessments (Albert's and Line Bisection Test) were used. The assessments were administered immediately before and after each of the 6 MNT sessions to assess the immediate effect of MNT. Moreover, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of MNT. Paired t-test was used to examine the immediate effect, and both participants showed significant improvement with Albert's Test in immediate effect.
- Conditions
- Hemispatial Neglect
- Being tested
- Musical Neglect Training
- Keywords
- Musical Neglect Training, Neurologic Music Therapy, unilateral visual neglect, hemispatial neglect, stroke, spatial perception and attention, music therapy
- Medical subject headings
- Perceptual Disorders, Stroke, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical Neglect TrainingOther
Also called Neurologic Music Therapy
MNT uses musical exercises which are structured in pitch, time and tempo, and musical equipment (tone bars, keyboards, drums) configures to focus attention to the neglect visual field.
| Study group | Role | What they receive |
|---|---|---|
| Musical Neglect Training (MNT) | Experimental | A single-subject design was used. All participants took Musical Neglect Training. Receives: Other: Musical Neglect Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Albert's Test between before and after the sessions
The Albert's Test was scored as the number of uncrossed lines on the sheet. The test paper consisted of 18 lines on each side, and 4 lines in the center. Since the un-crossed lines have been calculated, less score indicates positive outcomes.
Measured: Albert's test was given to participants before and after of all 6 sessions. The outcome measure was assessed two days a week for three weeks. Also, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of MNT.
Changes of Line Bisection Test between before and after the sessions
The Line Bisection Test was calculated as percentage of the deviation from the true center of the line. A different length of 17 lines were aligned horizontally on the test paper. Since the deviation from the true central point has been measured, less score indicates positive outcomes.
Measured: Line Bisection was given to participants before and after of all 6 sessions. The outcome measure was assessed two days a week for three weeks. Also, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of MNT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start27 Jan 2015
- Primary completion28 Jan 2016
- Study completion28 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemispatial NeglectStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Model description
- The same intervention has been used for all participants (two) for this study.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Principal investigator, Michael H. Thaut, University of Toronto
- Investigators
- Michael Thaut, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516825
- Sponsor's protocol ID
- 14-5432H
- Status last verified
- May 2018
- First submitted
- 19 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical Neglect Training for Unilateral Visual Neglect in Right Hemispheric Stroke Patients
- ClinicalTrials.gov ID
- NCT03516825
- Acronym / sponsor ID
- 14-5432H
- Conditions
- Hemispatial Neglect
- Keywords
- Musical Neglect Training, Neurologic Music Therapy, unilateral visual neglect, hemispatial neglect, stroke, spatial perception and attention, music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 28 Jan 2016 (actual)
- Study completion
- 28 Jan 2016 (actual)
- First posted
- 4 May 2018 (actual)
- 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.
Music Neglect Training has been developed for patients with hemispatial neglect to improve their attention on the left side. The purpose of this study was to examine the immediate and carry-over effect of Musical Neglect Training on unilateral visual neglect. Standardized assessments (Albert's test and Line Bisection Test) were used to measure a range of visual field. A total of 6 musical exercises with tone bars which are aligned horizontally helped to improve attention and perception of the visual field on the left side.
Detailed description
Unilateral visual neglect from right hemisphere stroke is a condition that reduces a person's ability to attend to and process stimuli in one half, mostly left side, of their environment. This perceptual processing deficit can negatively affect individuals' daily living which in turn reduces functional independence. Music has been used as a therapeutic tool in a variety of settings to promote cognitive functions. In particular, music has been used to improve attention in the left sides for patients with visual neglect. Musical Neglect Training (MNT) has been developed for patients with visual neglect to improve attention in the left side.
The purpose of this study was to examine the immediate and longer-lasting effect of Musical Neglect Training (MNT) on unilateral visual neglect. A single-subject design was used, as participants served as their own control. Two individuals participated in this study. Participants underwent six individual MNT sessions. MNT uses musical exercises which are structured in pitch, time and tempo, and musical equipment (tone bars, keyboards, drums) configures to focus attention to the neglect visual field. Two standardized assessments (Albert's and Line Bisection Test) were used. The assessments were administered immediately before and after each of the 6 MNT sessions to assess the immediate effect of MNT. Moreover, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of MNT. Paired t-test was used to examine the immediate effect, and both participants showed significant improvement with Albert's Test in immediate effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The same intervention has been used for all participants (two) for this study.
| Arm | Type | Receives |
|---|---|---|
| Musical Neglect Training (MNT) | Experimental | Other: Musical Neglect TrainingA single-subject design was used. All participants took Musical Neglect Training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients with visual neglect after stroke
- right-handed
- medically stable
- no previous music therapy experiences
- no hearing impairments
Key exclusion criteria (2 listed)
- hemianopia
- previous music therapy treatment experiences
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 |
|---|---|---|
| Musical Neglect TrainingAlso: Neurologic Music TherapyMNT uses musical exercises which are structured in pitch, time and tempo, and musical equipment (tone bars, keyboards, drums) configures to focus attention to the neglect visual field. | Other | Musical Neglect Training (MNT) |
Primary outcome
Changes of Albert's Test between before and after the sessions
Time frame: Albert's test was given to participants before and after of all 6 sessions. The outcome measure was assessed two days a week for three weeks. Also, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of MNT.
The Albert's Test was scored as the number of uncrossed lines on the sheet. The test paper consisted of 18 lines on each side, and 4 lines in the center. Since the un-crossed lines have been calculated, less score indicates positive outcomes.
Changes of Line Bisection Test between before and after the sessions
Time frame: Line Bisection was given to participants before and after of all 6 sessions. The outcome measure was assessed two days a week for three weeks. Also, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of MNT.
The Line Bisection Test was calculated as percentage of the deviation from the true center of the line. A different length of 17 lines were aligned horizontally on the test paper. Since the deviation from the true central point has been measured, less score indicates positive outcomes.
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 4 May 2018.
- Individual participant dataSharing planned: No. IPD will not be made available to external researchers.
Related trials for Hemispatial Neglect
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Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
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Cerebellum and Neglect
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Enrolling by invitation
Effectiveness of an Interactive Screen in the Rehabilitation of Neglect in Adults With Subacute Stroke: A Randomized Controlled Trial in Argentina.
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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.
Michael Thaut, PhD principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Musical Neglect Training in people with Hemispatial Neglect, run by University of Toronto.
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 6 inclusion and 2 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes of Albert's Test between before and after the sessions (time frame: Albert's test was given to participants before and after of all 6 sessions. The outcome measure was assessed two days a week for three weeks. Also, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of MNT.). 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 4 May 2018.