A Study Of Subscalp Placement Of The LINQII Device

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT07752251
Status
Enrolling By Invitation

Conditions

  • Cranial Neurosurgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Stereo-electrode (SEEG) Patients
    Patients undergoing a stereo-electrode (SEEG) procedure will have the LINQII device implanted temporarily
  • Experimental: Deep Brain Stimulation Patients
    Patients undergoing a deep brain stimulation procedure will have the LINQII device implanted temporarily

Primary Outcome Measure

Total number of recordings obtained [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-

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