Subscalp Placement Of The LINQII Device: A First-in-human Device Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Mayo Clinic
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Total number of recordings obtained
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Deep Brain Stimulation Patients
Patients undergoing a deep brain stimulation procedure will have the LINQII device implanted temporarily
Intervention: Medtronic LINQII (Device)
Stereo-electrode (SEEG) Patients
Patients undergoing a stereo-electrode (SEEG) procedure will have the LINQII device implanted temporarily
Intervention: Medtronic LINQII (Device)
Outcomes
Primary Outcomes
Total number of recordings obtained
Time Frame: Baseline
Number of subjects to have brain signal recordings obtained by the LINQII device.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jonathon J. Parker
Principal Investigator
Mayo Clinic