N/A
N=24
Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04184791 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Gait Kinematic Response for 180 and 60Hz DBS — 27.37; 29.05; 25.68; 28.31 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Deep Brain Stimulation (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait Kinematic Response for 180 and 60Hz DBS |
27.37; 29.05; 25.68; 28.31; 35.77; 36.44 | <0.05 sig |
| PRIMARY Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML) |
64 | — |
| SECONDARY Change in Hand Tremor Severity for 180 and 60Hz DBS |
0.19; 0.19; 0.51; 0.40; 0.23; 0.13 | — |
| SECONDARY Change in Speed of Limb Movements for 180 and 60Hz DBS |
2.65; 2.55; 2.76; 2.58; 2.85; 2.70 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT04184791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.