A High-density Microelectrode for Human Neuronal Recordings

NCT05919160 | Enrolling By Invitation FDA Device

• 1 other identifier: STUDY00002777
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the ability of a newly-designed electrode to measure the activity of individual nerve cells (neurons), and collections of nerve cells (local field potentials) in the brain. The study's main goals are to see how well this electrode works compared to standard electrodes and to validate its safety.

Conditions

Parkinson Disease, Idiopathic

Keywords

Parkinson's; DBS; Electrode

Outcome Measures

Primary Outcomes (2)

• Neuronal Activity

  Single Neuron firing rate (spikes) measured in spikes per second - total number of isolated neurons, amplitude (in uV of spikes) - by Intan Neurophysiology Recording System

  One week after recording in OR completed

• Breakage of Electrode

  Extent of fracture of electrode tip measured in micrometers by a light microscope

  One week after recording in OR completed

Study Arms (1)

Neuronal Recording and Behavioral Testing

EXPERIMENTAL

Neuronal Recording and Behavioral Testing

Device: DBC (Diagnostic Biochips) Deep Array microelectrode; Intan Electrophysiology recording system; Matlab response recording to behavioral task

Interventions

DBC (Diagnostic Biochips) Deep Array microelectrode; Intan Electrophysiology recording system; Matlab response recording to behavioral task DEVICE

Devices listed are components of a single intervention that includes: Record neuronal activity (Intan) from electrodes (DBC), record and analyze patient responses (Matlab)

Neuronal Recording and Behavioral Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing implantation of a Deep Brain Stimulating (DBS) electrode in the Subthalamic nucleus (STN) for the treatment of Parkinson's disease, in whom microelectrode recording is being performed to improve localization of the STN.
• Age \> 18 years of age
• Able to give independent informed consent

You may not qualify if:

• Microelectrode recording is not indicated
• Previous implantation of DBS electrodes in this site
• Known allergic reaction to stainless steel or polyimide

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Adam Mamelak, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 26, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)