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Personalized Real-Time DBS and PD Mechanisms

NCT06013956 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

DEVICE

Neurostimulation

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

DRUG

Carbidopa 25/Levodopa 100Mg Tab

Anti-parkinsonian medication.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • David Escobar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06013956 on ClinicalTrials.gov