Parkinson Disease Clinical Trial
— ENGAGE-PDOfficial title:
ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
NCT number | NCT05022147 |
Other study ID # | 21-739 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | October 4, 2021 |
Est. completion date | July 2024 |
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).
Status | Recruiting |
Enrollment | 12 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
James Liao |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stride Time Coefficient of Variation | Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors. | During the intervention | |
Primary | Percentage of Time with Tremor Present | Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors. | During the intervention | |
Primary | Tremor Amplitude | Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors. | During the intervention | |
Secondary | Total Freezing Time | Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors. | During the intervention | |
Secondary | Freezing Index | Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors. | During the intervention | |
Secondary | Gait Velocity | Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors. | During the intervention | |
Secondary | Step Cadence | Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors. | During the intervention | |
Secondary | 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. | During the intervention | |
Secondary | 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. | During the intervention |
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