NCT05733819

Responders to Rhythmic Auditory Cueing in Parkinson Disease

Completed Phase 1 Last updated 18 March 2024

What this trial tests

Phase 1 trial testing Subject-specific optimized RAS in Parkinson Disease in 31 participants. Completed in 30 June 2023.

Timeline

17 January 2023

Primary endpoint
20 June 2023

30 June 2023

Quick facts

Lead sponsor	Boston University Charles River Campus
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	17 January 2023
Primary completion	20 June 2023
Estimated completion	30 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Subject-specific optimized RAS
• Active Walking

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Boston University Charles River Campus

Who can join

Adults 18 to 80, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Parkinson disease (PD) is the second most common neurodegenerative disease affecting approximately 10 million people worldwide. It is a complex movement disorder that results in reduced walking ability. Prior studies have identified declines in walking as a marker of ensuing disability. Rhythmic auditory stimulation (RAS) is a rehabilitation approach that employs the coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting regular moderate-intensity walking activity -- an important health objective in the management of PD. However, there is limited research investigating the effects of RAS on walking quality and how improvements in walking speed are achieved. This study will enroll 30 individuals with mild to moderate PD where each participant will be asked to complete two six-minute walk tests, one standard test (baseline) and the other using an optimized metronome-based auditory cueing RAS intervention. The investigators hypothesize that individuals with PD will either walk farther or with more automaticity (i.e., reduced stride time variability) in the RAS condition compared to the baseline condition. Moreover, these walking improvements will be accompanied by improvements in gait mechanics and metabolic cost of walking.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.