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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184791
• Other study ID #: 19-0217
• Secondary ID: R21NS111301
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2024
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Northwell Health	Great Neck	New York

Sponsors (3)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Neurological Disorders and Stroke (NINDS), The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Kinematic Response for 180 and 60Hz DBS	The measurements of interest were captured during the instrumented walk. Interaction of DBS Frequency and Levodopa on gait kinematics was assessed using LM-ANOVA.	1-2 minute period with each stimulation condition in the Medicated and Unmedicated states.
Primary	Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML)	We apply ML techniques to a data set of gait kinematics acquired from instrumented walking assessments and utilize random forest ML algorithms to identify participants' stimulation frequency/medication condition.	2 years
Secondary	Change in Hand Tremor Severity for 180 and 60Hz DBS	The difference in tremor (e.g. rest, postural) severity will be measured with the kinesia sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states on a severity scale from 0-4. Higher number = worse outcome	1 minute test session for each stimulation condition
Secondary	Change in Speed of Limb Movements for 180 and 60Hz DBS	The difference in the speed of limb movements (e.g. hand grasps and leg lifts) will be measured with the kinesia sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states on a severity scale of 0-4. Higher values = worse outcome.	1 minute test session for each stimulation condition