Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2026-05-31

Brief Summary

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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).

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Detailed Description

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Postural instability, gait impairment, and falls are among the greatest unmet needs in Parkinson disease (PD). A single fall can be catastrophic, and impairments that limit mobility lead to social isolation or depression, and adversely affect bone and cardiovascular health. Unfortunately, postural instability and gait disorders are refractory to current pharmacological and surgical treatments, including deep brain stimulation (DBS). This project will directly address this pressing need. We will recruit participants to perform a gait task, using a new, alternating DBS frequency paradigm, while body movements and neural signals are recorded. The findings will lead to improved therapies to address these symptoms in the future.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

On a single day, participants will switch between six DBS frequency conditions. Gait and body kinematics will be monitored during these conditions. The order that participants experience the six conditions will be randomized, and participants will be blinded to the condition. In addition, the assessments will be performed OFF and then repeated ON medication.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

There is only one arm in the study. Participants will be masked to which device intervention is active, but they will not be masked to the medication state.

Study Groups

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Alternating-Frequency DBS

In this single-arm study, all participants will receive all interventions in a crossover fashion.

Group Type EXPERIMENTAL

High-Frequency-Only Stimulation

Intervention Type DEVICE

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

Low-Frequency-Only Stimulation

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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.

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

Intervention Type DEVICE

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.

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

Intervention Type DEVICE

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.

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

Intervention Type DEVICE

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.

OFF Dopaminergic Medication

Intervention Type DRUG

All six device interventions will be performed in medication OFF state

ON Dopaminergic Medication

Intervention Type DRUG

All six device interventions will be performed in medication ON state

Interventions

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High-Frequency-Only Stimulation

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

Intervention Type DEVICE

Low-Frequency-Only Stimulation

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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

OFF Dopaminergic Medication

All six device interventions will be performed in medication OFF state

Intervention Type DRUG

ON Dopaminergic Medication

All six device interventions will be performed in medication ON state

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Bilateral STN DBS for PD
* Medtronic Percept PC implanted DBS battery/pulse generator/recording system
* Presence of balance and/or walking impairment and/or freezing of gait
* Can walk without assistance, OFF meds, based on yes/no verbal response

Exclusion Criteria

* Severity of gait impairment should not require dependency to walker or cane
* Cannot tolerate monopolar stimulation at either of the two middle electrode contacts (prerequisite for the recording mode of the DBS) at high frequency (130 Hz) or low frequency (60 Hz).
* Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases
* Contraindication to physical therapy
* Age \< 21
* Diagnosis of dementia
* Not agreeable to having video taken of entire research visit

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No