Personalized Real-Time DBS and PD Mechanisms
Identifying Circuit Dynamics Underlying Motor Dysfunction in Parkinson's Disease Using Real-Time Neural Control
1 other identifier
interventional
25
1 country
1
Brief Summary
A prospective cohort of patients scheduled to undergo deep brain stimulation (DBS) implantation surgery for the treatment of Parkinson's disease as per standard of care will be invited to participate in this study. This mechanistic study is aimed at better understanding the role of basal ganglia beta band (11-35 Hz) oscillations and resonance in the manifestation of Parkinson's disease (PD) motor signs using closed-loop electrical neurostimulation, levodopa medication, and computational modeling. The ultimate goal of this study is to inform the development of closed-loop neuromodulation technology that can be programmed and adjusted in real time based on patient-specific neural activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 parkinson-disease
Started Aug 2023
Longer than P75 for phase_4 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedStudy Start
First participant enrolled
August 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 14, 2025
May 1, 2025
4.8 years
August 22, 2023
May 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Effect of eiDBS suppression vs. off-stimulation on finger tapping speed
The finger tapping speed will be measured with an inertial measuring unit. The relationship (slope/effect) between this kinematic variable (response variable) and the mean amplitude of beta (11-35 Hz) oscillations (predictor physiological variable) will be estimated via linear mixed-effects (LME) models. The LME models will include the stimulation conditions in this study (e.g., eiDBS-suppression) as fixed effects with the off-stimulation condition as a reference/control group, and random intercepts as random effects that account for the heterogeneity between subjects.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS amplification vs. off-stimulation on finger tapping speed
The relationship (slope/effect) between the kinematic variable (response variable) and the mean amplitude of beta (11-35 Hz) oscillations (predictor physiological variable) will be estimated via linear mixed-effects (LME) models.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS suppression vs. off-stimulation on forearm speed
The forearm speed will be measured with an inertial measuring unit. The relationship (slope/effect) between this kinematic variable (response variable) and the mean amplitude of beta (11-35 Hz) oscillations (predictor physiological variable) will be estimated via linear mixed-effects (LME) models.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS amplification vs. off-stimulation on forearm speed
The relationship (slope/effect) between the kinematic variable (response variable) and the mean amplitude of beta (11-35 Hz) oscillations (predictor physiological variable) will be estimated via linear mixed-effects (LME) models.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS suppression vs. off-stimulation on UPDRS-III rigidity subscore
The relationship (slope/effect) between this UPDRS-III rigidity subscore (response variable) and the mean amplitude of beta (11-35 Hz) oscillations (predictor physiological variable) will be estimated via linear mixed-effects (LME) models.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS amplification vs. off-stimulation on UPDRS-III rigidity subscore
The relationship (slope/effect) between this UPDRS-III rigidity subscore (response variable) and the mean amplitude of beta (11-35 Hz) oscillations (predictor physiological variable) will be estimated via linear mixed-effects (LME) models.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Correlation between levodopa-related changes in finger tapping speed and the amplitude of stimulation-evoked beta oscillations
The amplitude of beta oscillations evoked by stimulation will be characterized using the wavelet transform. The relationship (slope) between the kinematic measurements (response variable) and the beta oscillations amplitude (predictor variable) will be estimated via the linear mixed-effects models.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Correlation between levodopa-related changes in forearm speed and the amplitude of stimulation-evoked beta oscillations
The relationship (slope) between the kinematic measurements (response variable) and the beta oscillations amplitude (predictor variable) will be estimated via the linear mixed-effects models.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Correlation between levodopa-related changes in UPDRS-III rigidity subscore and the amplitude of stimulation-evoked beta oscillations.
The relationship (slope) between the UPDRS-III subscores (response variable) and the beta oscillations amplitude (predictor variable) will be estimated via the linear mixed-effects models.
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Secondary Outcomes (9)
Effect of eiDBS suppression vs. off-stimulation on finger tapping displacement
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS amplification vs. off-stimulation on finger tapping displacement
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS suppression vs. off-stimulation on forearm displacement
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS amplification vs. off-stimulation on forearm displacement
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
Effect of eiDBS suppression vs. off-stimulation on UPDRS-III bradykinesia subscore
Data will be collected in assessment blocks multiple times throughout enrollment. Assessments will be performed for up to nine days, starting the day after the DBS surgery. Assessments may also be performed in one visit 3-12 months after DBS surgery.
- +4 more secondary outcomes
Study Arms (4)
eiDBS suppression
EXPERIMENTALClosed-loop evoked interference DBS that suppresses beta oscillations.
Off DBS
NO INTERVENTIONOff-stimulation and off-medication
eiDBS amplification
EXPERIMENTALClosed-loop evoked interference DBS that amplifies beta oscillations.
Levodopa medication
EXPERIMENTALOn-medication, off-stimulation
Interventions
Electrical stimulation delivered via deep brain stimulation electrodes based on measurements of brain activity.
Eligibility Criteria
You may qualify if:
- Ability to provide informed consent.
- Clinical diagnosis of idiopathic Parkinson's disease.
- Determined, as per standard of care, to be a candidate for deep brain stimulation (DBS) surgery targeting the subthalamic nucleus.
- Ability to tolerate delays in taking daily standard Parkinson's disease medications.
You may not qualify if:
- Secondary Parkinsonism, stroke, or progressive central nervous system disease other than Parkinson's disease.
- Patient has a condition that, in the opinion of the investigators, would significantly increase the risk of interfering with study compliance, safety, or outcome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Escobarlead
- The Cleveland Cliniccollaborator
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- The sequence order for the conditions will be randomized for each study participant.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Staff
Study Record Dates
First Submitted
August 22, 2023
First Posted
August 28, 2023
Study Start
August 29, 2023
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
May 14, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be shared immediately following publication. There is no end date for this data sharing.
- Access Criteria
- Data sharing requests should be directed to escobad2@ccf.org. To gain access, data requestors may need to sign a data access agreement.
Individual participant data that underlie the results reported in the published articles (text, tables, figures, and appendices), after deidentification, will be shared.