Back to resultsEnhancing Gait Using Alternating-Frequency DBS in Parkinson Disease (ENGAGE-PD)
Primary Purpose
Parkinson Disease, Gait Disorders, Neurologic, Disease Progression
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High-Frequency-Only Stimulation
Low-Frequency-Only Stimulation
Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation
Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation
Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation
Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation
OFF Dopaminergic Medication
ON Dopaminergic Medication
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Postural Instability, Gait Impairment, Freezing of Gait, DBS, Frequency, Low, Alternating, Variable, High
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic FoundationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alternating-Frequency DBS
Arm Description
In this single-arm study, all participants will receive all interventions in a crossover fashion.
Outcomes
Primary Outcome Measures
Stride Time Coefficient of Variation
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Percentage of Time with Tremor Present
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
Tremor Amplitude
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
Secondary Outcome Measures
Total Freezing Time
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Freezing Index
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Gait Velocity
Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors.
Step Cadence
Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors.
LFP and EEG power spectrum correlation with behavior and kinematics
Neural recordings (LFP = Local Field Potential and EEG = Electroencephalogram) from the DBS electrode and from EEG electrodes will be analyzed in the frequency domain. Assessed frequency bands will include delta, theta, alpha, beta, and gamma activity. These will be correlated with behavior and kinematic recordings to determine the neural correlates of gait instability and other parkinsonian symptoms.
LFP and EEG connectivity correlation with behavior and kinematics
Neural recordings (LFP = Local Field Potential and EEG = Electroencephalogram) consist of multiple channels of simultaneously measured electrical activity. Connectivity is a measure of correlations between each pair of recorded and postprocessed channels, at each frequency band, over time. A machine learning algorithm will be trained to correlate the connectivity to behavior and kinematic recordings, to determine the neural correlates of gait instability and other parkinsonian symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05022147
Brief Title
Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
Acronym
ENGAGE-PD
Official Title
ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Liao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic, Disease Progression, Subthalamic Nucleus, Accidental Fall, Deep Brain Stimulation
Keywords
Postural Instability, Gait Impairment, Freezing of Gait, DBS, Frequency, Low, Alternating, Variable, High
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alternating-Frequency DBS
Arm Type
Experimental
Arm Description
In this single-arm study, all participants will receive all interventions in a crossover fashion.
Intervention Type
Device
Intervention Name(s)
High-Frequency-Only Stimulation
Intervention Description
Control condition, constant high-frequency DBS stimulation (130Hz)
Intervention Type
Device
Intervention Name(s)
Low-Frequency-Only Stimulation
Intervention Description
Experimental condition, constant low-frequency DBS stimulation (60 Hz)
Intervention Type
Device
Intervention Name(s)
Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation
Intervention Description
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
Intervention Name(s)
Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation
Intervention Description
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
Intervention Name(s)
Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation
Intervention Description
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
Intervention Name(s)
Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation
Intervention Description
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
Drug
Intervention Name(s)
OFF Dopaminergic Medication
Intervention Description
All six device interventions will be performed in medication OFF state
Intervention Type
Drug
Intervention Name(s)
ON Dopaminergic Medication
Intervention Description
All six device interventions will be performed in medication ON state
Primary Outcome Measure Information:
Title
Stride Time Coefficient of Variation
Description
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
During the intervention
Title
Percentage of Time with Tremor Present
Description
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
During the intervention
Title
Tremor Amplitude
Description
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
During the intervention
Secondary Outcome Measure Information:
Title
Total Freezing Time
Description
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
During the intervention
Title
Freezing Index
Description
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
During the intervention
Title
Gait Velocity
Description
Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
During the intervention
Title
Step Cadence
Description
Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
During the intervention
Title
LFP and EEG power spectrum correlation with behavior and kinematics
Description
Neural recordings (LFP = Local Field Potential and EEG = Electroencephalogram) from the DBS electrode and from EEG electrodes will be analyzed in the frequency domain. Assessed frequency bands will include delta, theta, alpha, beta, and gamma activity. These will be correlated with behavior and kinematic recordings to determine the neural correlates of gait instability and other parkinsonian symptoms.
Time Frame
During the intervention
Title
LFP and EEG connectivity correlation with behavior and kinematics
Description
Neural recordings (LFP = Local Field Potential and EEG = Electroencephalogram) consist of multiple channels of simultaneously measured electrical activity. Connectivity is a measure of correlations between each pair of recorded and postprocessed channels, at each frequency band, over time. A machine learning algorithm will be trained to correlate the connectivity to behavior and kinematic recordings, to determine the neural correlates of gait instability and other parkinsonian symptoms.
Time Frame
During the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Liao, MD PhD
Phone
216-445-1108
Email
liaoj2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Liao, MD PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
At time of publication, a point of contact individual on the study team will be identified. Third parties will be able to request access to de-identified data used to support the publication findings by application to the Cleveland Clinic IRB. A data use agreement will be put in place between the CCF Cleveland Clinic and this third party for approved use of the data.
Learn more about this trial
Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
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