A Phase 2 interventional study of Self Cueing Training and External Cueing Training in Parkinson Disease, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to compare to rhythm-based walking interventions to enhance gait in people with Parkinson's disease. The main questions it aims to answer are:
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 74 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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4) stable on all Parkinson disease medications for at least 2 months prior to study entry 5) willing and able to provide informed consent 6) right-handed
Exclusion Criteria:
Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.
Behavioral: Self Cueing Training
External cueing using music, one hour sessions twice weekly for 12 weeks.
Behavioral: External Cueing Training
Group classes led by a music therapist and using singing as a self-generated cue, with a focus on rhythm perception, rhythm generation and synchronization of movement to rhythms.
Group classes led by a music therapist and using music as an external cue, with a focus on rhythm perception, rhythm generation and synchronization of movement to rhythms.
Gait Speed
How quickly someone walks
Time frame: Baseline and 12 weeks
MRI Bold Beta Weights
Measure of blood oxygen levels in different brain regions indicative of level of activity within different brain regions. 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 to the beat during self cueing (mental singing) and move to the beat 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.
Time frame: Baseline and 12 weeks
Participants were recruited from our movement disorders clinic and through presentations at local support groups and conferences. The study was also advertised on social media.
| Milestone | Self Cueing | External Cueing |
|---|---|---|
| Started | 38 | 36 |
| Completed | 28 | 33 |
| Not completed | 10 | 3 |
How quickly someone walks
| meters per second | Self Cueing | External Cueing |
|---|---|---|
| Baseline gait speed | 1.09 ± 0.20 | 1.04 ± 0.23 |
| Gait speed at 12 weeks | 1.15 ± 0.21 | 1.08 ± 0.22 |
Measure of blood oxygen levels in different brain regions indicative of level of activity within different brain regions. 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 to the beat during self cueing (mental singing) and move to the beat 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.
| Beta weights (arbitrary units) | Self Cueing | External Cueing |
|---|---|---|
| Baseline bilateral auditory cortex activity when tapping during mental singing | -.892 ± .323 | -.764 ± .323 |
| 12 weeks bilateral auditory cortex activity when tapping during mental singing | -.854 ± .277 | -.674 ± .378 |
| Baseline left putamen activity when tapping during mental singing | -.018 ± .197 | -.023 ± .210 |
| 12 weeks left putamen activity when tapping to mental singing | .060 ± .186 | -.093 ± .156 |
| Baseline bilateral anterior cerebellum activity when tapping during mental singing | -.023 ± .293 | .014 ± .220 |
| 12 weeks bilateral anterior cerebellum activity when tapping during mental singing | .044 ± .275 | -.035 ± .199 |
| Baseline bilateral auditory cortex activity when tapping to music | .492 ± .286 | .249 ± .500 |
| 12 week bilateral auditory cortex activity when tapping to music | .324 ± .236 | .339 ± .309 |
| Baseline left putamen activity when tapping to music | .097 ± .197 | -.035 ± .178 |
| 12 week left putamen activity when tapping to music | -.039 ± .151 | -.045 ± .209 |
| Baseline bilateral anterior cerebellum activity when tapping to music | .060 ± .131 | .047 ± .230 |
| 12 week bilateral anterior cerebellum activity when tapping to music | -.024 ± .112 | -.024 ± .246 |
Collected over From enrollment to end of follow-up, up to 20 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Self Cueing | 0/38 (0%) | 0/38 (0%) | 15/38 (39.5%) |
| External Cueing | 0/36 (0%) | 0/36 (0%) | 7/36 (19.4%) |
| Event | Self Cueing | External Cueing |
|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 4/38 | 1/36 |
| FallMusculoskeletal and connective tissue disorders | 3/38 | 1/36 |
| Feeling unwellRespiratory, thoracic and mediastinal disorders | 3/38 | 0/36 |
| DizzinessNervous system disorders | 0/38 | 2/36 |
| Foot painMusculoskeletal and connective tissue disorders | 2/38 | 1/36 |
| FractureMusculoskeletal and connective tissue disorders | 2/38 | 1/36 |
| Skin conditionSkin and subcutaneous tissue disorders | 1/38 | 1/36 |
| Age, Continuous(years) | Self Cueing | External Cueing | Total |
|---|---|---|---|
| Mean | 67.8 ± 7.5 | 67.2 ± 7.9 | 67.5 ± 7.6 |
| Sex: Female, Male(Participants) | Self Cueing | External Cueing | Total |
|---|---|---|---|
| Female | 20 | 16 | 36 |
| Male | 18 | 20 | 38 |
| Race (NIH/OMB)(Participants) | Self Cueing | External Cueing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 0 | 1 | 1 |
| White | 36 | 33 | 69 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Self Cueing | External Cueing | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 38 | 36 | 74 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Hoehn & Yahr Stage(Participants) | Self Cueing | External Cueing | Total |
|---|---|---|---|
| Hoehn & Yahr Stage 2 | 35 | 32 | 67 |
| Hoehn & Yahr Stage 3 | 3 | 4 | 7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Data for individual participants available by request. Only de-identified data will be shared and only for individuals who consent to have their data shared with people who are not part of the original research team.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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