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Personalized Real-Time DBS for Parkinson's Disease

This study is for people with Parkinson's disease who are planning to have Deep Brain Stimulation (DBS) surgery. Researchers want to understand how electrical stimulation delivered through DBS electrodes, along with Carbidopa 25/Levodopa 100Mg Tab (a common Parkinson's medication), affects brain activity and movement. The goal is to see if adjusting DBS in real-time, based on your brain's signals, can improve finger tapping and forearm speed. You can join if you are 18 to 80 years old, have Parkinson's disease, are scheduled for DBS surgery, and can manage delays in your regular Parkinson's medications. The study aims to enroll 25 participants and is currently unclear on its recruitment status.

Study design
This is an interventional study involving 25 participants. It is designed to understand how different types of electrical stimulation from DBS affect motor symptoms.
What's involved
You would have assessments multiple times for up to nine days, starting the day after DBS surgery. There may also be one follow-up visit 3-12 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Assessments may be performed in one visit 3-12 months after DBS surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06013956

Personalized Real-Time DBS and PD Mechanisms

Recruiting
PHASE4Ages 18–80InterventionalBasic science
David Escobar
~25 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:NeurostimulationCarbidopa 25/Levodopa 100Mg Tab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effect of eiDBS suppression vs. off-stimulation on finger tapping speed
Measured over 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.
+8 more outcomes measured

Conditions

Parkinson Disease

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Parkinson Disease

NCT06013956

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

David Escobar, PhD
[email protected]
216-390-1907
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Effect of eiDBS suppression vs. off-stimulation on finger tapping speedData 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.

    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.

  • Effect of eiDBS amplification vs. off-stimulation on finger tapping speedData 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.

    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.

  • Effect of eiDBS suppression vs. off-stimulation on forearm speedData 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.

    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.

  • Effect of eiDBS amplification vs. off-stimulation on forearm speedData 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.

    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.

  • Effect of eiDBS suppression vs. off-stimulation on UPDRS-III rigidity subscoreData 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.

    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.

  • Effect of eiDBS amplification vs. off-stimulation on UPDRS-III rigidity subscoreData 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.

    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.

  • Correlation between levodopa-related changes in finger tapping speed and the amplitude of stimulation-evoked beta oscillationsData 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.

    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.

  • Correlation between levodopa-related changes in forearm speed and the amplitude of stimulation-evoked beta oscillationsData 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.

    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.

  • Correlation between levodopa-related changes in UPDRS-III rigidity subscore and the amplitude of stimulation-evoked beta oscillations.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.

    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.