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Enrolling by invitation NCT07752251

A Study Of Subscalp Placement Of The LINQII Device

No phase Interventional Cranial Neurosurgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medtronic LINQII.
Who it may be relevant to
Registry conditions: Cranial Neurosurgery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Subscalp Placement Of The LINQII Device: A First-in-human Device Feasibility Study

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.

Interventions

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

Primary outcome measures

  • Total number of recordings obtained [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Mayo Clinic in Arizona — Scottsdale

Identifiers

NCT: NCT07752251 · 25-003456

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗