NCT05022147

Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: James Liao · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess how alternating-frequency Deep Brain Stimulation (DBS) works to improve postural instability and gait, while also treating other motor symptoms of Parkinson Disease (PD).

Detailed description

Postural instability, gait impairment, and falls are among the greatest unmet needs in Parkinson disease (PD). A single fall can be catastrophic, and impairments that limit mobility lead to social isolation or depression, and adversely affect bone and cardiovascular health. Unfortunately, postural instability and gait disorders are refractory to current pharmacological and surgical treatments, including deep brain stimulation (DBS). This project will directly address this pressing need. We will recruit participants to perform a gait task, using a new, alternating DBS frequency paradigm, while body movements and neural signals are recorded. The findings will lead to improved therapies to address these symptoms in the future.

Conditions

• Parkinson Disease
• Gait Disorders, Neurologic
• Disease Progression
• Subthalamic Nucleus
• Accidental Fall
• Deep Brain Stimulation

Interventions

Type	Name	Description
DEVICE	High-Frequency-Only Stimulation	Control condition, constant high-frequency DBS stimulation (130Hz)
DEVICE	Low-Frequency-Only Stimulation	Experimental condition, constant low-frequency DBS stimulation (60 Hz)
DEVICE	Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation	Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 50 seconds for high, and 10 seconds for low, respectively.
DEVICE	Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation	Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 50 seconds for high, and 50 seconds for low, respectively.
DEVICE	Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation	Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 10 seconds for high, and 50 seconds for low, respectively.
DEVICE	Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation	Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 10 seconds for high, and 10 seconds for low, respectively.
DRUG	OFF Dopaminergic Medication	All six device interventions will be performed in medication OFF state
DRUG	ON Dopaminergic Medication	All six device interventions will be performed in medication ON state

Timeline

• Start date: 2021-10-04
• Primary completion: 2024-11-15
• Completion: 2026-05-01
• First posted: 2021-08-26
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study