Cranial Neurosurgery
Conditions
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.
Interventions
DEVICEMedtronic LINQII
Bilateral LINQII devices will be implanted under the scalp during surgery to obtain approximately 30 minutes of brain signal recordings.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of recordings obtained | Baseline | Number of subjects to have brain signal recordings obtained by the LINQII device. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathon J. Parker, MD, PhD
Mayo Clinic
Outcome results
None listed