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Completed

NCT Number: NCT04184791

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

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwell Health

Great Neck, New York, 11021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

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

Primary outcomes

  1. Gait Kinematic Response for 180 and 60Hz DBS

    Time frame: 1-2 minute period with each stimulation condition in the Medicated and Unmedicated states.

    The measurements of interest were captured during the instrumented walk. Interaction of DBS Frequency and Levodopa on gait kinematics was assessed using LM-ANOVA.

  2. Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML)

    Time frame: 2 years

    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.

Secondary outcomes

  1. Change in Hand Tremor Severity for 180 and 60Hz DBS

    Time frame: 1 minute test session for each stimulation condition

    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

  2. Change in Speed of Limb Movements for 180 and 60Hz DBS

    Time frame: 1 minute test session for each stimulation condition

    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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • The University of Tennessee, Knoxville

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2019
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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