Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

Summary

The purpose of this study is to assess how alternating-frequency Deep Brain Stimulation (DBS) works to improve postural instability and gait, while also treating other motor symptoms of Parkinson Disease (PD).

Conditions

• Parkinson Disease
• Gait Disorders, Neurologic
• Disease Progression
• Subthalamic Nucleus
• Accidental Fall
• Deep Brain Stimulation

Interventions

DEVICE

Low-Frequency-Only Stimulation

Experimental condition, constant low-frequency DBS stimulation (60 Hz)

DEVICE

High-Frequency-Only Stimulation

Control condition, constant high-frequency DBS stimulation (130Hz)

DEVICE

Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation

Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 50 seconds for high, and 10 seconds for low, respectively.

DEVICE

Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation

Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 50 seconds for high, and 50 seconds for low, respectively.

DEVICE

Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation

Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 10 seconds for high, and 50 seconds for low, respectively.

DEVICE

Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation

Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 10 seconds for high, and 10 seconds for low, respectively.

DRUG

OFF Dopaminergic Medication

All six device interventions will be performed in medication OFF state

DRUG

ON Dopaminergic Medication

All six device interventions will be performed in medication ON state

Sponsors & Collaborators

• James Liao

  lead OTHER

Principal Investigators

• James Liao, MD PhD · The Cleveland Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-04

Primary Completion

2024-11-15

Completion

2026-05-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations