A Study Of Subscalp Placement Of The LINQII Device

NCT07752251 | Enrolling By Invitation FDA Device

• 1 other identifier: 25-003456
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cranial Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Total number of recordings obtained

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

  Baseline

Study Arms (2)

Stereo-electrode (SEEG) Patients

EXPERIMENTAL

Patients undergoing a stereo-electrode (SEEG) procedure will have the LINQII device implanted temporarily

Device: Medtronic LINQII

Deep Brain Stimulation Patients

EXPERIMENTAL

Patients undergoing a deep brain stimulation procedure will have the LINQII device implanted temporarily

Device: Medtronic LINQII

Interventions

Medtronic LINQII DEVICE

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

Deep Brain Stimulation Patients; Stereo-electrode (SEEG) Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Jonathon J. Parker, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)