NCT04184791

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

Completed NA Results posted Last updated 15 March 2024

What this trial tests

NA trial testing Deep Brain Stimulation in Parkinson Disease in 24 participants. Completed in 31 August 2022.

Timeline

15 January 2020

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	Northwell Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	15 January 2020
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Deep Brain Stimulation

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 21 to 80, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Gait Kinematic Response for 180 and 60Hz DBS Primary · 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.

Right Toe off Angle

Group	Value	95% CI
180HZ (OFF MED)	27.37	± 1.08
180Hz (ON Med)	29.05	± 1.09
60Hz (OFF Med)	25.68	± 1.08
60Hz (ON MED)	28.31	± 1.09

Right Single Limb Support

Group	Value	95% CI
180HZ (OFF MED)	35.77	± 0.56
180Hz (ON Med)	36.44	± 0.56
60Hz (OFF Med)	35.10	± 0.56
60Hz (ON MED)	36.47	± 0.56

Left Foot Stance

Group	Value	95% CI
180HZ (OFF MED)	64.23	± 0.55
180Hz (ON Med)	63.48	± 0.56
60Hz (OFF Med)	64.94	± 0.55
60Hz (ON MED)	63.52	± 0.56

Left Foot Swing

Group	Value	95% CI
180HZ (OFF MED)	35.77	± 0.55
180Hz (ON Med)	36.52	± 0.56
60Hz (OFF Med)	35.07	± 0.55
60Hz (ON MED)	36.48	± 0.56

Left Arm Range of Motion

Group	Value	95% CI
180HZ (OFF MED)	19.13	± 1.94
180Hz (ON Med)	25.37	± 1.99
60Hz (OFF Med)	17.98	± 1.95
60Hz (ON MED)	20.48	± 1.98

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

Group	Value	95% CI
Subthalamic-DBS at 60Hz and 180Hz in the Levodopa OFF and ON State.	64

Change in Hand Tremor Severity for 180 and 60Hz DBS Secondary · 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

Left Rest Tremor

Group	Value	95% CI
180Hz DBS (OFF Med)	0.19	± 0.08
180Hz (ON Med)	0.19	± 0.08
60Hz (OFF Med)	0.51	± 0.08
60Hz (ON Med)	0.40	± 0.08

Left Hand Postural Tremor

Group	Value	95% CI
180Hz DBS (OFF Med)	0.23	± 0.09
180Hz (ON Med)	0.13	± 0.09
60Hz (OFF Med)	0.66	± 0.09
60Hz (ON Med)	0.46	± 0.09

Right Hand Rest Tremor

Group	Value	95% CI
180Hz DBS (OFF Med)	0.27	± 0.12
180Hz (ON Med)	0.23	± 0.11
60Hz (OFF Med)	0.57	± 0.12
60Hz (ON Med)	0.45	± 0.11

Right Hand Postural Tremor

Group	Value	95% CI
180Hz DBS (OFF Med)	0.22	± 0.09
180Hz (ON Med)	0.16	± 0.10
60Hz (OFF Med)	0.58	± 0.10
60Hz (ON Med)	0.42	± 0.10

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

Left Hand Movement Speed

Group	Value	95% CI
180Hz (OFF MED	2.65	± 0.11
180Hz (ON Med)	2.55	± 0.11
60Hz (OFF Med)	2.76	± 0.11
60Hz (ON Med)	2.58	± 0.11

Right Hand Movement Speed

Group	Value	95% CI
180Hz (OFF MED	2.85	± 0.11
180Hz (ON Med)	2.70	± 0.11
60Hz (OFF Med)	2.90	± 0.11
60Hz (ON Med)	2.73	± 0.11

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. On the Right Track to Treat Movement Disorders: Promising Therapeutic Approaches for Parkinson's and Huntington's Disease.
   Troncoso-Escudero P, Sepulveda D, Pérez-Arancibia R, Parra AV, et al · · 2020 · cited 22× · PMID 33101007 · DOI 10.3389/fnagi.2020.571185