A Study Of Subscalp Placement Of The LINQII Device

N/AEnrolling By InvitationNCT07752251

Mayo Clinic10 enrolled

Overview

The purpose of this to evaluate the capability of the FDA approved Medtronic LINQ II device (implantable cardiac monitoring device) to record EEG signals when placed temporarily in the subscalp space in patients undergoing cranial neurosurgery. No disease-directed therapeutic efficacy endpoints will be studied.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Cranial Neurosurgery

Interventions

Medtronic LINQIIDEVICE

Bilateral LINQII devices will be implanted under the scalp during surgery to obtain approximately 30 minutes of brain signal recordings.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18-80 years old. * Undergoing (or expected to undergo) intracranial EEG electrode or deep brain stimulator placement surgery as part of clinical standard of care. Exclusion Criteria: * Patients deemed by the neurosurgery team to be at elevated risk of infection or hemorrhage because of the study procedure. * Individuals who cannot provide informed consent, do not have an available legally authorized representative, or are part of vulnerable or protected populations. * Pregnant or breast-feeding female participants. * Women of childbearing potential will be screened prior to surgery following standard of care procedures.

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Total number of recordings obtained

Number of subjects to have brain signal recordings obtained by the LINQII device.

Time frame: Baseline

Data from ClinicalTrials.gov

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