NCT04184791

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

November 22, 2019

Results QC Date

August 24, 2023

Last Update Submit

February 14, 2024

Conditions

Parkinson Disease

Keywords

Deep Brain StimulationParkinson's DiseaseWearable Sensors

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 years

Secondary Outcomes (2)

  • Change in Hand Tremor Severity for 180 and 60Hz DBS

    1 minute test session for each stimulation condition

  • Change in Speed of Limb Movements for 180 and 60Hz DBS

    1 minute test session for each stimulation condition

Study Arms (2)

Deep Brain Stimulation(DBS) OFF Medication

EXPERIMENTAL

Subthalamic-DBS in the Levodopa OFF state.

Device: Deep Brain Stimulation

Deep Brain Stimulation(DBS) ON Medication

EXPERIMENTAL

Subthalamic-DBS in the Levodopa ON state.

Device: Deep Brain Stimulation

Interventions

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.

Deep Brain Stimulation(DBS) OFF MedicationDeep Brain Stimulation(DBS) ON Medication

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwell Health

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Ritesh Ramdhani
Organization
Feinstein Institute for Medical Research at Northwell
rramdhani@northwell.edu
516-325-7000

Study Officials

  • Ritesh Ramdhani, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

November 22, 2019

First Posted

December 4, 2019

Study Start

January 15, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

March 15, 2024

Results First Posted

March 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)