Recruiting

DBS with Levodopa

Sponsor:

David Escobar

Code:

NCT06013956

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neurostimulation

Carbidopa 25/Levodopa 100Mg Tab

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT06013956

Start date

Aug 29, 2023

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: eiDBS suppression

Closed-loop evoked interference DBS that suppresses beta oscillations.

no intervention: Off DBS

Off-stimulation and off-medication

experimental: eiDBS amplification

Closed-loop evoked interference DBS that amplifies beta oscillations.

experimental: Levodopa medication

On-medication, off-stimulation

Interventions

Neurostimulation

Electrical stimulation delivered via deep brain stimulation electrodes based on measurements of brain activity.

Carbidopa 25/Levodopa 100Mg Tab

Anti-parkinsonian medication.

Primary outcome measure

  • Effect of eiDBS suppression vs. off-stimulation on finger tapping speed [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

David Escobar, PhD

216-390-1907escobad2@ccf.org

Jeffrey Negrey, MA

216-316-6896negreyj2@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

David Escobar, PhD

216-390-1907escobad2@ccf.org

Jeffrey Negrey, MA

216-316-6896negreyj2@ccf.org

More Information

Sponsor

David Escobar

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Deep Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Escobar on 2026-08-20.