Sing For Your Saunter Part 2 R33

NCT06115382 | Completed Phase 2 Results DMC

• 1 other identifier: 202309088
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• How does rhythm-based training influence walking performance?
• How does brain activity change following rhythm-based training? Participants will perform walking to music and walking while singing, and will train on the use of these rhythms for 12 weeks. The investigators will compare the effects of training with music to training with singing.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Gait Speed

  How quickly someone walks

  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.

  Baseline and 12 weeks

Study Arms (2)

Self cueing

EXPERIMENTAL

Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.

Behavioral: Self Cueing Training

External cueing

EXPERIMENTAL

External cueing using music, one hour sessions twice weekly for 12 weeks.

Behavioral: External Cueing Training

Interventions

Self Cueing Training BEHAVIORAL

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.

Self cueing

External Cueing Training BEHAVIORAL

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.

External cueing

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 30 years of age
• diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria
• Hoehn \& Yahr stages 2-3 (mild to moderate disease severity)
• evidence of walking impairment (score at least 1 on gait item of MDS\_UPDRS)
• \) 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

You may not qualify if:

• diagnosis of any other neurological condition
• a score of 2 or greater on item # 3 on the freezing of gait questionnaire
• 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
• orthopedic problems in the lower extremities or spine that may limit walking
• contraindications for magnetic resonance imaging
• unable to walk for 10 continuous minutes independently
• left-handed
• uncontrolled tremor or dyskinesia

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Nothing to report

Results Point of Contact

• Title: Gammon Earhart
• Organization: Washington University in St. Louis

earhartg@wustl.edu

314-286-1407

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: November 3, 2023
• Study Start: October 5, 2023
• Primary Completion: October 14, 2025
• Study Completion: December 21, 2025
• Last Updated: April 2, 2026
• Results First Posted: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)