NCT04184791

Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to further the understanding and application of 60Hz subthalamic deep brain stimulation (STN-DBS) in Parkinson's patients with gait disorder. The investigators will achieve this through 2 study aims: 1. Determine the impact of 60Hz subthalamic deep brain stimulation on gait kinematics using wearable sensors 2. Develop machine learning models to predict optimal subthalamic deep brain stimulation frequency based on wearable sensors

Detailed description

Gait disorder, which manifests as shuffling, reduction in speed, multistep turning, and/or freezing of gait (FOG), can arise later in the Parkinson's disease (PD) course and cause significant disability. Ultimately, patients are at risk for falls and can become socially isolated due to their mobility limitations. These symptoms tend not to respond to high frequency STN-DBS. However, lower frequency stimulation (60-80Hz) of the STN in treating gait disorder and/or freezing of gait has demonstrated benefit. This study potentially can expand knowledge of 60hz DBS while improving its utilization in combination with PD medications-enabling sustainable and possibly predictable therapeutic benefit.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	Each DBS electrode contact will be reprogrammed in 60hz and High Frequency Stimulation (180hz) in the Levodopa ON (medicated) and OFF (unmedicated) conditions.

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2019-12-04
• Last updated: 2024-03-15
• Results posted: 2024-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study