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

Northwell Health

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04184791

R21NS111301 (U.S. NIH Grant/Contract)

19-0217

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, aged 21-80
2. Patients diagnosed with Parkinson's disease (PD)
3. PD subjects who have bilateral STN-DBS (greater than 3 months) or in the preoperative stage of being implanted with bilateral STN-DBS
4. Have underlying gait disorder
5. Currently treated with oral levodopa therapy
6. Willingness to comply with all study procedures

Exclusion criteria

1. Cognitive deficits based on historical record that limit participant compliance with study protocol
2. Vestibular disorder or musculoskeletal problems affecting gait or balance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Deep Brain Stimulation(DBS) OFF Medication

Experimental group

Description:

Subthalamic-DBS in the Levodopa OFF state.

Treatment:

Device: Deep Brain Stimulation

Deep Brain Stimulation(DBS) ON Medication

Experimental group

Description:

Subthalamic-DBS in the Levodopa ON state.

Treatment:

Device: Deep Brain Stimulation