Parkinson DiseaseNCT04184791

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

A study testing Deep Brain Stimulation in people with Parkinson Disease, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 80 years
Conditions the study is for: Parkinson Disease
What is being tested?: Deep Brain Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2020to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Cognitive deficits based on historical record that limit participant compliance with study protocol
Vestibular disorder or musculoskeletal problems affecting gait or balance

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwell Health
Great Neck, New York, 11021

Other trials in United States

About this study

Determine the impact of 60Hz subthalamic deep brain stimulation on gait kinematics using wearable sensors
Develop machine learning models to predict optimal subthalamic deep brain stimulation frequency based on wearable sensors

Read the 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.

Conditions: Parkinson Disease
Being tested: Deep Brain Stimulation
Keywords: Deep Brain Stimulation, Parkinson's Disease, Wearable Sensors
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04184791
Study group	Role	What they receive
Deep Brain Stimulation(DBS) OFF Medication	Experimental	Subthalamic-DBS in the Levodopa OFF state. Receives: Device: Deep Brain Stimulation
Deep Brain Stimulation(DBS) ON Medication	Experimental	Subthalamic-DBS in the Levodopa ON state. Receives: Device: Deep Brain Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Gait Kinematic Response for 180 and 60Hz DBS
The measurements of interest were captured during the instrumented walk. Interaction of DBS Frequency and Levodopa on gait kinematics was assessed using LM-ANOVA.
Measured: 1-2 minute period with each stimulation condition in the Medicated and Unmedicated states.
Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML)
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.
Measured: 2 years

Secondary outcomes (2)

Change in Hand Tremor Severity for 180 and 60Hz DBS
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
Measured: 1 minute test session for each stimulation condition
Change in Speed of Limb Movements for 180 and 60Hz DBS
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.
Measured: 1 minute test session for each stimulation condition

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202031 Aug 2022

First posted4 Dec 2019
Study start15 Jan 2020
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Northwell HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04184791
Sponsor's protocol ID: 19-0217
Other IDs: R21NS111301
Status last verified: Feb 2024
First submitted: 22 Nov 2019
Last updated: 15 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
ClinicalTrials.gov ID: NCT04184791
Acronym / sponsor ID: 19-0217
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation, Parkinson's Disease, Wearable Sensors
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), The University of Tennessee, Knoxville
Study start: 15 Jan 2020 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 4 Dec 2019 (actual)
Results: Posted 15 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Determine the impact of 60Hz subthalamic deep brain stimulation on gait kinematics using wearable sensors
Develop machine learning models to predict optimal subthalamic deep brain stimulation frequency based on wearable sensors

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Deep Brain Stimulation(DBS) OFF Medication	Experimental	Device: Deep Brain StimulationSubthalamic-DBS in the Levodopa OFF state.
Deep Brain Stimulation(DBS) ON Medication	Experimental	Device: Deep Brain StimulationSubthalamic-DBS in the Levodopa ON state.

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (2 listed)

Cognitive deficits based on historical record that limit participant compliance with study protocol
Vestibular disorder or musculoskeletal problems affecting gait or balance

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Deep Brain StimulationEach DBS electrode contact will be reprogrammed in 60hz and High Frequency Stimulation (180hz) in the Levodopa ON (medicated) and OFF (unmedicated) conditions.	Device	Deep Brain Stimulation(DBS) OFF Medication, Deep Brain Stimulation(DBS) ON Medication

Primary outcome

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.
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.

2 secondary outcomes

Change in Hand Tremor Severity for 180 and 60Hz DBS
Time frame: 1 minute test session for each stimulation condition
Change in Speed of Limb Movements for 180 and 60Hz DBS
Time frame: 1 minute test session for each stimulation condition

Results and safety

Results posted to the registry on 15 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study	24	22

Primary outcome: Gait Kinematic Response for 180 and 60Hz DBS

Time frame: 1-2 minute period with each stimulation condition in the Medicated and Unmedicated states.. Least squares mean (Standard Error). Unit: units on a scale

Measure	180HZ (OFF MED) n = 22	180Hz (ON Med) n = 22	60Hz (OFF Med) n = 22	60Hz (ON MED) n = 22
Right Toe off Angle	27.37 (1.08)	29.05 (1.09)	25.68 (1.08)	28.31 (1.09)
Right Single Limb Support	35.77 (0.56)	36.44 (0.56)	35.10 (0.56)	36.47 (0.56)
Left Foot Stance	64.23 (0.55)	63.48 (0.56)	64.94 (0.55)	63.52 (0.56)
Left Foot Swing	35.77 (0.55)	36.52 (0.56)	35.07 (0.55)	36.48 (0.56)
Left Arm Range of Motion	19.13 (1.94)	25.37 (1.99)	17.98 (1.95)	20.48 (1.98)

180HZ (OFF MED) vs 180Hz (ON Med) vs 60Hz (OFF Med): p <0.05, Mixed Models Analysis

Population analysed: 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)

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

Time frame: 2 years. Number. Unit: percentage of random forest accuracy

Measure	Subthalamic-DBS at 60Hz and 180Hz in the Levodopa OFF and ON State. n = 21
Value	64

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events was assessed during each study visit day. At total of 2-3 study visits over 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OFF Medication/OFF DBS	0 of 24 (0%)	0 of 24 (0%)	0 of 24
ON Medication/ OFF DBS	0 of 24 (0%)	0 of 24 (0%)	0 of 24
60Hz DBS (OFF Med)	0 of 24 (0%)	0 of 24 (0%)	0 of 24
60Hz DBS (ON Med)	0 of 24 (0%)	0 of 24 (0%)	0 of 24
180Hz (OFF Med)	0 of 24 (0%)	0 of 24 (0%)	0 of 24
180Hz (ON Med)	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ritesh Ramdhani, MD principal investigator

Northwell Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulation in people with Parkinson Disease, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04184791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.