Trial Outcomes & Findings for Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease (NCT NCT04184791)

Last Updated: 2024-03-15

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

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

Results posted on

2024-03-15

Participant Flow

All Subjects were recruited through the Movement Disorders Center at Northwell Health, NY.

Participant milestones

Participant milestones
Measure	Overall Study 4 Phases: I - OFF DBS/OFF MED II- 180Hz DBS/ON MED III- 60Hz DBS/ON MED IV: OFF DBS/ON MED
OFF Med/OFF DBS STARTED	24
OFF Med/OFF DBS COMPLETED	22
OFF Med/OFF DBS NOT COMPLETED	2
180Hz DBS ( OFF MED) STARTED	24
180Hz DBS ( OFF MED) COMPLETED	22
180Hz DBS ( OFF MED) NOT COMPLETED	2
180Hz (ON MED) STARTED	24
180Hz (ON MED) COMPLETED	22
180Hz (ON MED) NOT COMPLETED	2
60Hz DBS (OFF MED) STARTED	24
60Hz DBS (OFF MED) COMPLETED	22
60Hz DBS (OFF MED) NOT COMPLETED	2
60Hz (ON Med) STARTED	24
60Hz (ON Med) COMPLETED	22
60Hz (ON Med) NOT COMPLETED	2
ON MED/OFF DBS STARTED	24
ON MED/OFF DBS COMPLETED	22
ON MED/OFF DBS NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deep Brain Stimulation(DBS) OFF & ON Medication n=22 Participants Subthalamic-DBS in the Levodopa OFF and ON state. Deep Brain Stimulation: Each DBS electrode contact will be reprogrammed in 60hz and High Frequency Stimulation (180hz) in the OFF (unmedicated) and ON (medicated) conditions.
Age, Continuous	63.6 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants
PD Phenotype Tremor Dominant	4 Participants n=5 Participants
PD Phenotype Postural Instability and Gait Disorder(PIGD)	6 Participants n=5 Participants
PD Phenotype Intermediate	12 Participants n=5 Participants

PRIMARY outcome

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

Population: Scale range 0-100 ( toe angle - higher value is a better outcome; Single limb support - higher value is better outcome; left foot stance % - higher value is worse outcome; left foot swing - higher value is better outcome; left arm range of motion - higher value is better outcome)

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

Outcome measures

Outcome measures
Measure	180HZ (OFF MED) n=22 Participants DBS at 180Hz in the OFF Levodopa states	180Hz (ON Med) n=22 Participants DBS at 180Hz in the On Levodopa state	60Hz (OFF Med) n=22 Participants DBS at 60Hz in the OFF Levodopa state	60Hz (ON MED) n=22 Participants DBS at 60Hz in the On Levodopa state
Gait Kinematic Response for 180 and 60Hz DBS Left Foot Stance	64.23 units on a scale Standard Error 0.55	63.48 units on a scale Standard Error 0.56	64.94 units on a scale Standard Error 0.55	63.52 units on a scale Standard Error 0.56
Gait Kinematic Response for 180 and 60Hz DBS Right Toe off Angle	27.37 units on a scale Standard Error 1.08	29.05 units on a scale Standard Error 1.09	25.68 units on a scale Standard Error 1.08	28.31 units on a scale Standard Error 1.09
Gait Kinematic Response for 180 and 60Hz DBS Right Single Limb Support	35.77 units on a scale Standard Error 0.56	36.44 units on a scale Standard Error 0.56	35.10 units on a scale Standard Error 0.56	36.47 units on a scale Standard Error 0.56
Gait Kinematic Response for 180 and 60Hz DBS Left Foot Swing	35.77 units on a scale Standard Error 0.55	36.52 units on a scale Standard Error 0.56	35.07 units on a scale Standard Error 0.55	36.48 units on a scale Standard Error 0.56
Gait Kinematic Response for 180 and 60Hz DBS Left Arm Range of Motion	19.13 units on a scale Standard Error 1.94	25.37 units on a scale Standard Error 1.99	17.98 units on a scale Standard Error 1.95	20.48 units on a scale Standard Error 1.98

PRIMARY outcome

Timeframe: 2 years

Population: The random forest classifier's predictive accuracy for discriminating OFF DBS/OFF MED condition from alternative DBS/MED conditions is listed below.

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.

Outcome measures

Outcome measures
Measure	180HZ (OFF MED) n=21 Participants DBS at 180Hz in the OFF Levodopa states	180Hz (ON Med) DBS at 180Hz in the On Levodopa state	60Hz (OFF Med) DBS at 60Hz in the OFF Levodopa state	60Hz (ON MED) DBS at 60Hz in the On Levodopa state
Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML)	64 percentage of random forest accuracy	—	—	—

SECONDARY outcome

Timeframe: 1 minute test session for each stimulation condition

Population: There was significant difference between rest and postural tremor between 60Hz and 180hz

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

Outcome measures

Outcome measures
Measure	180HZ (OFF MED) n=22 Participants DBS at 180Hz in the OFF Levodopa states	180Hz (ON Med) n=22 Participants DBS at 180Hz in the On Levodopa state	60Hz (OFF Med) n=22 Participants DBS at 60Hz in the OFF Levodopa state	60Hz (ON MED) n=22 Participants DBS at 60Hz in the On Levodopa state
Change in Hand Tremor Severity for 180 and 60Hz DBS Left Rest Tremor	0.19 score on a scale Standard Error 0.08	0.19 score on a scale Standard Error 0.08	0.51 score on a scale Standard Error 0.08	0.40 score on a scale Standard Error 0.08
Change in Hand Tremor Severity for 180 and 60Hz DBS Left Hand Postural Tremor	0.23 score on a scale Standard Error 0.09	0.13 score on a scale Standard Error 0.09	0.66 score on a scale Standard Error 0.09	0.46 score on a scale Standard Error 0.09
Change in Hand Tremor Severity for 180 and 60Hz DBS Right Hand Rest Tremor	0.27 score on a scale Standard Error 0.12	0.23 score on a scale Standard Error 0.11	0.57 score on a scale Standard Error 0.12	0.45 score on a scale Standard Error 0.11
Change in Hand Tremor Severity for 180 and 60Hz DBS Right Hand Postural Tremor	0.22 score on a scale Standard Error 0.09	0.16 score on a scale Standard Error 0.10	0.58 score on a scale Standard Error 0.10	0.42 score on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: 1 minute test session for each stimulation condition

Population: There were no significant difference between groups

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.