Personalized Real-Time DBS and PD Mechanisms

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
David Escobar
Study ID
NCT06013956
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Neurostimulation — DEVICE
    Electrical stimulation delivered via deep brain stimulation electrodes based on measurements of brain activity.
  • Carbidopa 25/Levodopa 100Mg Tab — DRUG
    Anti-parkinsonian medication.

Study Details

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.

Key Dates

Start date
Aug 29, 2023
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
David Escobar, PhD
[email protected]
216-390-1907
Jeffrey Negrey, MA
[email protected]
216-316-6896

Find similar trials in Cleveland, OH

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Cleveland Clinic· Cleveland, OH

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