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Sing for Your Saunter (SFYS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04246476
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : January 29, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gammon M Earhart, Washington University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment
Parkinson Disease Behavioral: Mentally singing Behavioral: Listening to music

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Sing for Your Saunter: Using Self-generated Rhythmic Cues to Enhance Gait in Parkinson's
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson disease
People living with Parkinson disease.
Behavioral: 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.

Behavioral: Listening to music
All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat.

Controls
Age-matched controls.
Behavioral: 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.

Behavioral: Listening to music
All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat.




Primary Outcome Measures :
  1. Stride Time Variability [ Time Frame: Baseline ]
    Measured with wearable sensors by APDM Wearable Technology

  2. Gait Speed [ Time Frame: Baseline ]
    Measured with wearable sensors by APDM Wearable Technology


Secondary Outcome Measures :
  1. Blood Oxygen Level Dependent Signal (BOLD) during movement [ Time Frame: Baseline ]
    Measure of the ratio of oxygenated to deoxygenated blood in the putamen, cortical motor areas, and cerebellum between individuals with PD and age-matched controls. Higher values indicate more brain activity in the brain areas.

  2. Blood Oxygen Level Dependent Signal (BOLD) when listening to music vs. mentally singing [ Time Frame: Baseline ]
    Measure of the ratio of oxygenated to deoxygenated blood in the putamen and cortical motor areas for both groups. Higher values indicate more brain activity in the brain areas during listening to music vs mentally singing.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Recruitment of participants with PD will primarily be through the Movement Disorders Clinic in the Department of Neurology at Washington University School of Medicine, flyers, social media, and the American Parkinson Disease Association St. Louis Chapter advertisements.

Recruitment of age-matched controls will be primarily through the Washington University Older Adults Participant Pool from the Department of Psychological and Brain Sciences at Washington University in St. Louis, Washington University Research Participant Registry, Volunteers for Health, and community advertisements via flyers, social media, and newsletters.

Criteria

Inclusion Criteria for all participants:

  • at least 30 years of age;
  • willing and able to provide informed consent;
  • right-handed or ambidextrous;
  • normal hearing;
  • weight less than 250 lbs; and
  • able to walk for 10 continuous minutes independently.

Inclusion criteria for participants with PD also include:

  • diagnosis of idiopathic, typical Parkinson disease according to the United Kingdom Brain Bank Criteria;
  • Hoehn & Yahr stages 2-3 (mild to moderate disease severity);
  • stable on all PD medications for at least 2 months prior to study entry;
  • a score of 1 or less on item # 7 on the New Freezing of Gait Questionnaire; and
  • score of ≥ 1 on the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III Item #10 indicating observable gait impairment.

Exclusion Criteria for both groups include:

  • diagnosis of any other neurological condition;
  • significant cognitive impairment;
  • unstable medical or concomitant illnesses or psychiatric conditions which, in the opinion of the investigators, would preclude successful participation;
  • cardiac problems that interfere with ability to safely participate (i.e., uncontrolled congestive heart failure, myocardial infarction in past 6 months, complex cardiac arrhythmias, significant left ventricular dysfunction, dyspnea on exertion, chest pain or pressure, resting tachycardia (>100 beats/min); uncontrolled BP (resting systolic BP >160 mmHg or diastolic BP >100 mmHg));
  • orthopedic problems in the lower extremities or spine that may limit walking (i.e., severe arthritis, spinal stenosis);
  • contraindications for magnetic resonance imaging (e.g., metallic implants); or
  • uncontrolled tremor or dyskinesia (while on PD medications if applicable).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246476


Locations
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United States, Missouri
Washington University School of Medicine Program in Physical Therapy
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Gammon Earhart Washington University School of Medicine
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Responsible Party: Gammon M Earhart, Director, Program in Physical Therapy, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04246476    
Other Study ID Numbers: 201908117
1R61AT010753-01 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gammon M Earhart, Washington University School of Medicine:
parkinson disease
music
imaging
mental singing
gait
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases