Clinical trial NCT04184791: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Parkinson's Disease
Wearable Sensors
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: The University of Tennessee, Knoxville
First posted: 2019-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait Kinematic Response for 180 and 60Hz DBS
timeFrame: 1-2 minute period with each stimulation condition in the Medicated and Unmedicated states.
measure: Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML)
timeFrame: 2 years
Secondary outcomes:
measure: Change in Hand Tremor Severity for 180 and 60Hz DBS
timeFrame: 1 minute test session for each stimulation condition
measure: Change in Speed of Limb Movements for 180 and 60Hz DBS
timeFrame: 1 minute test session for each stimulation condition
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: Northwell Health
name: Ritesh Ramdhani, MD
role: PRINCIPAL_INVESTIGATOR
References: