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

NCT ID: NCT04184791

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2022-08-31

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. 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Deep Brain Stimulation(DBS) OFF Medication

Subthalamic-DBS in the Levodopa OFF state.

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: DEVICE

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) ON Medication

Subthalamic-DBS in the Levodopa ON state.

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: DEVICE

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

Interventions

Deep Brain Stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged 21-80

2. Patients diagnosed with Parkinson's disease (PD)

3. PD subjects who have bilateral STN-DBS (greater than 3 months) or in the preoperative stage of being implanted with bilateral STN-DBS

4. Have underlying gait disorder

5. Currently treated with oral levodopa therapy

6. Willingness to comply with all study procedures

Exclusion Criteria

1. Cognitive deficits based on historical record that limit participant compliance with study protocol

2. Vestibular disorder or musculoskeletal problems affecting gait or balance

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Ritesh Ramdhani, MD

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ritesh Ramdhani, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Northwell Health

Great Neck, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21NS111301

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0217

Identifier Type: -

Identifier Source: org_study_id