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

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ClinicalTrials.gov Identifier: NCT04184791
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : August 20, 2020
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
The University of Tennessee, Knoxville
Information provided by (Responsible Party):
Ritesh Ramdhani, MD, Northwell Health

Tracking Information
First Submitted Date  ICMJE November 22, 2019
First Posted Date  ICMJE December 4, 2019
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE January 15, 2020
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2019)
  • Change in Gait and Balance using Wearable Sensors [ Time Frame: 1-2 minute period with each stimulation condition ]
    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 [ Time Frame: 2 years ]
    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 [ Time Frame: 2 years ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2019)
  • Change in Hand Tremor Severity [ Time Frame: 1 minute test session for each stimulation condition ]
    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 [ Time Frame: 1 minute test session for each stimulation condition ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
Official Title  ICMJE Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
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:

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Deep Brain Stimulation(DBS) OFF Medication
    Subthalamic-DBS in the Levodopa OFF state.
    Intervention: Device: Deep Brain Stimulation
  • Experimental: Deep Brain Stimulation(DBS) ON Medication
    Subthalamic-DBS in the Levodopa ON state.
    Intervention: Device: Deep Brain Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 6 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. Non-English speaking
  2. Cognitive deficits based on historical record that limit participant compliance with study protocol
  3. Vestibular disorder or musculoskeletal problems affecting gait or balance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Toni Fitzpatrick 516-562-2685 tfitzpatrick@northwell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04184791
Other Study ID Numbers  ICMJE 19-0217
R21NS111301 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ritesh Ramdhani, MD, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • The University of Tennessee, Knoxville
Investigators  ICMJE
Principal Investigator: Ritesh Ramdhani, MD Northwell Health
PRS Account Northwell Health
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP