Identifying Circuit Dynamics Underlying Motor Dysfunction in Parkinson's Disease Using Real-Time Neural Control

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
David Escobar, PhD
escobad2@ccf.org
216-390-1907
Backup
Jeffrey Negrey, MA
negreyj2@ccf.org
216-316-6896
Time Frame
Start Date: 2023-08-29
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 25
Treatments
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
Sponsors
Collaborators: The Cleveland Clinic
Leads: David Escobar

This content was sourced from clinicaltrials.gov