Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Deep Brain Stimulation, Parkinson's Disease, Wearable Sensors
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 21-80
- Patients diagnosed with Parkinson's disease (PD)
- PD subjects who have bilateral STN-DBS (greater than 3 months) or in the preoperative stage of being implanted with bilateral STN-DBS
- Have underlying gait disorder
- Currently treated with oral levodopa therapy
- Willingness to comply with all study procedures
Exclusion Criteria:
- Cognitive deficits based on historical record that limit participant compliance with study protocol
- Vestibular disorder or musculoskeletal problems affecting gait or balance
Sites / Locations
- Northwell Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Deep Brain Stimulation(DBS) OFF Medication
Deep Brain Stimulation(DBS) ON Medication
Arm Description
Subthalamic-DBS in the Levodopa OFF state.
Subthalamic-DBS in the Levodopa ON state.
Outcomes
Primary Outcome Measures
Change in Gait and Balance using Wearable Sensors
Inertial Sensors will be used to quantify gait metrics (postural sway, gait cycle, circumduction) as participants conduct two 7meter walking trials for each stimulation condition ( 60Hz frequency or High Frequency) across DBS electrode pairs in both the medicated and unmedicated states.
Accuracy of Predicting Gait Response to 60hz with Machine Learning
Regression models will be created using non-linear regression analysis based on random forest (RF) classifier on the raw gait sensor data acquired from the medicated and unmedicated states.
Accuracy of Predicting Best Stimulation Frequency (60hz vs. High Frequency) with Machine Learning
Regression models will be created using non-linear regression analysis based on random forest (RF) classifier on all raw sensor data (gait and balance, tremor, and speed of limb movements) acquired in the medicated and unmedicated states.
Secondary Outcome Measures
Change in Hand Tremor Severity
The difference in tremor (e.g. rest, postural, kinetic) severity will be measured with an Inertial sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states.
Change in Speed of Limb Movements
The difference in the speed of limb movements (e.g. finger taps, hand grasps, wrist rotation, leg lifts, toe taps) will be measured with an Inertial sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states.
Full Information
NCT ID
NCT04184791
First Posted
November 22, 2019
Last Updated
August 14, 2023
Sponsor
Northwell Health
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), The University of Tennessee, Knoxville
1. Study Identification
Unique Protocol Identification Number
NCT04184791
Brief Title
Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
Official Title
Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), The University of Tennessee, Knoxville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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:
Determine the impact of 60Hz subthalamic deep brain stimulation on gait kinematics using wearable sensors
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation, Parkinson's Disease, Wearable Sensors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation(DBS) OFF Medication
Arm Type
Experimental
Arm Description
Subthalamic-DBS in the Levodopa OFF state.
Arm Title
Deep Brain Stimulation(DBS) ON Medication
Arm Type
Experimental
Arm Description
Subthalamic-DBS in the Levodopa ON state.
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Each DBS electrode contact will be reprogrammed in 60hz and High Frequency Stimulation (180hz) in the Levodopa ON (medicated) and OFF (unmedicated) conditions.
Primary Outcome Measure Information:
Title
Change in Gait and Balance using Wearable Sensors
Description
Inertial Sensors will be used to quantify gait metrics (postural sway, gait cycle, circumduction) as participants conduct two 7meter walking trials for each stimulation condition ( 60Hz frequency or High Frequency) across DBS electrode pairs in both the medicated and unmedicated states.
Time Frame
1-2 minute period with each stimulation condition
Title
Accuracy of Predicting Gait Response to 60hz with Machine Learning
Description
Regression models will be created using non-linear regression analysis based on random forest (RF) classifier on the raw gait sensor data acquired from the medicated and unmedicated states.
Time Frame
2 years
Title
Accuracy of Predicting Best Stimulation Frequency (60hz vs. High Frequency) with Machine Learning
Description
Regression models will be created using non-linear regression analysis based on random forest (RF) classifier on all raw sensor data (gait and balance, tremor, and speed of limb movements) acquired in the medicated and unmedicated states.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in Hand Tremor Severity
Description
The difference in tremor (e.g. rest, postural, kinetic) severity will be measured with an Inertial sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states.
Time Frame
1 minute test session for each stimulation condition
Title
Change in Speed of Limb Movements
Description
The difference in the speed of limb movements (e.g. finger taps, hand grasps, wrist rotation, leg lifts, toe taps) will be measured with an Inertial sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states.
Time Frame
1 minute test session for each stimulation condition
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 21-80
Patients diagnosed with Parkinson's disease (PD)
PD subjects who have bilateral STN-DBS (greater than 3 months) or in the preoperative stage of being implanted with bilateral STN-DBS
Have underlying gait disorder
Currently treated with oral levodopa therapy
Willingness to comply with all study procedures
Exclusion Criteria:
Cognitive deficits based on historical record that limit participant compliance with study protocol
Vestibular disorder or musculoskeletal problems affecting gait or balance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritesh Ramdhani, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
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