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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AT010753-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Older adults, and particularly those with Parkinson disease (PD), may experience walking difficulties that negatively impact their daily function and quality of life. This project will examine the impact of music and mentally singing on walking performance, with a goal of understanding what types of rhythmic cues are most helpful. Our pilot work suggests that imagined, mental singing (i.e., singing in your head) while while walking helps people walk faster with greater stability, whereas walking to music also helps people walk faster but with reduced stability.
In Aim 1, the investigators will compare walking while mentally singing to walking while listening to music, using personalized cues tailored to each person's walking performance. The investigators hypothesize stride time variability will be less in the mental singing condition compared to listening to music; and that mental singing and listening to music will improve gait speed similarly as compared to the uncued condition. The investigators will also test whether finger tapping, a rhythmic task similar to walking in many ways, responds similarly while mentally singing and listening to music.
In Aim 2, the investigator will investigate the brain mechanisms underlying the enhancements in movement performance seen with mental signing or listening to music. The investigators will use magnetic resonance imaging (MRI) to measure brain activity during finger tapping with and without various cues to understand which areas of the brain are more or less responsive to the cues. The investigators hypothesize individuals with PD will exhibit lesser activation of putamen and greater activation of cortical motor areas and cerebellum compared to controls in all tapping conditions; and internal, mental singing during tapping will elicit greater activation of the putamen and lesser activation of cortical motor areas in both groups compared to uncued tapping and tapping while listening to music.
During this observational study, all participants will attend two visits 4-10 days apart. At the first visit, all participants (participants with PD and age-matched controls) will wear wearable sensors during the following tasks: walking with no cues; walking while listening to music; and walking while mentally singing. The wearable sensors will measure gait parameters including gait speed and stride time variability. All participants will also conduct the following tasks while finger tapping on a keyboard: tapping with no cues; tapping while listening to music; and tapping while mentally singing.
At the second visit, all participants (participants with PD and age-matched controls) will perform the following tasks during imaging: uncued tapping; listening to music (no tapping); mentally singing (no tapping); listening to music and tapping; and mentally singing and tapping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self cueing | Experimental | People living with Parkinson disease and controls walking with self-generated rhythmic cues. |
|
| External cueing | Active Comparator | People living with Parkinson disease and controls walking to external rhythmic cues (i.e., music). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentally singing | Behavioral | All participants (people with PD and age-matched controls) sing their song in their head and match their footfalls or finger tapping to the beat. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed | Measured with wearable sensors by APDM Wearable Technology | Baseline |
| Stride Length Variability | Measured with wearable sensors by APDM Wearable Technology | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Activity (BOLD Signal) | We analyzed the Blood Oxygen Level Dependent (BOLD) signal in the brain to determine where there were areas of significant changes in brain activity, relative to rest, when participants were moving with no cue (uncued), moving to the beat during self cueing (mental singing) and moving to the best during external cueing (music). BOLD values are reported are Beta weights. Positive values indicate an increase in activity relative to rest and negative values indicate a decrease in activity relative to rest. |
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Inclusion Criteria for all participants:
Inclusion criteria for participants with PD also include:
Exclusion Criteria for both groups include:
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| Name | Affiliation | Role |
|---|---|---|
| Gammon Earhart | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine Program in Physical Therapy | St Louis | Missouri | 63110 | United States |
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All participants in both groups completed all conditions (i.e., uncued, mental singing and music) at all tempos (i.e., 90, 100, 110 and 120% of baseline uncued cadence).
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| ID | Title | Description |
|---|---|---|
| FG000 | Parkinson Disease Group | People living with Parkinson disease |
| FG001 | Healthy Controls | Healthy controls age-matched to Parkinson disease group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Reporting results separately for group with PD and healthy controls, though both groups were assigned to same walking conditions
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| ID | Title | Description |
|---|---|---|
| BG000 | Parkinson Group | People living with Parkinson disease walking with and without rhythmic cues. Mentally singing: All participants (people with PD and age-matched controls) sing their song in their head and match their footfalls or finger tapping to the beat. Music: All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat. Uncued: no music and no singing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gait Speed | Measured with wearable sensors by APDM Wearable Technology | Results are presented separately for each group and for each cueing condition (uncued, music or mental singing) and tempo (90, 100, 110, 120%). | Posted | Mean | Standard Deviation | meters per second | Baseline |
|
Monitoring of participants during two separate visits of a few hours each on 2 different days no more than 2 weeks apart.
Participants were supervised throughout their time in the two sessions so adverse events were monitored continuously
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parkinson Disease Group | Individuals with Parkinson disease | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gammon Earhart | Washington University in St. LOuis | 3142861407 | earhartg@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2023 | Apr 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Listening to music | Behavioral | All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat. |
|
| Baseline |
| BG001 | Healthy Control Group | Healthy controls walking with and without rhythmic cues. Mentally singing: All participants (people with PD and age-matched controls) sing their song in their head and match their footfalls or finger tapping to the beat. Music: All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat. Uncued: no music and no singing |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Mini Mental Status Exam | Scores on the Mini Mental Status range from 0 to 30, with higher scores indicating better cognitive function. Scores below 26 indicate cognitive impairment. | Median | Full Range | units on a scale |
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| Units | Counts |
|---|
| Participants |
|
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| Primary | Stride Length Variability | Measured with wearable sensors by APDM Wearable Technology | Results are presented separately for each group in each condition (uncued, music, mental singing) at each tempo (90, 100, 110, 120% of uncued). | Posted | Mean | Standard Deviation | coefficient of variation | Baseline |
|
|
|
| Secondary | Brain Activity (BOLD Signal) | We analyzed the Blood Oxygen Level Dependent (BOLD) signal in the brain to determine where there were areas of significant changes in brain activity, relative to rest, when participants were moving with no cue (uncued), moving to the beat during self cueing (mental singing) and moving to the best during external cueing (music). BOLD values are reported are Beta weights. Positive values indicate an increase in activity relative to rest and negative values indicate a decrease in activity relative to rest. | Results are presented separately for each group in each condition (uncued, music, mental singing). | Posted | Mean | Standard Deviation | Beta weights (arbitrary units) | Baseline |
|
|
|
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Healthy Control Group | Healthy controls age-matched to Parkinson disease group | 0 | 29 | 0 | 29 | 0 | 29 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Mental singing 90% |
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| Music 100% |
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| Mental singing 100% |
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| Music 110% |
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| Mental singing 110% |
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| Music 120% |
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| Mental singing 120% |
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| Uncued Bilateral Primary Somatosensory Cortex |
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| Music Left Putamen |
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| Music Right Putamen |
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| Music Bilateral Auditory Cortex |
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| Music Bilateral Primary Somatosensory Cortex |
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| Mental singing Left Putamen |
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| Mental Singing Right Putamen |
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| Mental singing Bilateral Primary Somatosensory Cortex |
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