Cranial NeurosurgeryNCT07752251
A Study Of Subscalp Placement Of The LINQII Device
A study testing Medtronic LINQII in people with Cranial Neurosurgery, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cranial Neurosurgery
- What is being tested?
- Medtronic LINQII
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Subscalp Placement Of The LINQII Device: A First-in-human Device Feasibility Study
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
- Being tested
- Medtronic LINQII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic LINQIIDevice
Bilateral LINQII devices will be implanted under the scalp during surgery to obtain approximately 30 minutes of brain signal recordings.
| Study group | Role | What they receive |
|---|---|---|
| Stereo-electrode (SEEG) Patients | Experimental | Patients undergoing a stereo-electrode (SEEG) procedure will have the LINQII device implanted temporarily Receives: Device: Medtronic LINQII |
| Deep Brain Stimulation Patients | Experimental | Patients undergoing a deep brain stimulation procedure will have the LINQII device implanted temporarily Receives: Device: Medtronic LINQII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of recordings obtained
Number of subjects to have brain signal recordings obtained by the LINQII device.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial NeurosurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathon J. Parker, Mayo Clinic
- Investigators
- Jonathon J. Parker, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752251
- Sponsor's protocol ID
- 25-003456
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subscalp Placement Of The LINQII Device: A First-in-human Device Feasibility Study
- ClinicalTrials.gov ID
- NCT07752251
- Acronym / sponsor ID
- 25-003456
- Conditions
- Cranial Neurosurgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereo-electrode (SEEG) Patients | Experimental | Device: Medtronic LINQIIPatients undergoing a stereo-electrode (SEEG) procedure will have the LINQII device implanted temporarily |
| Deep Brain Stimulation Patients | Experimental | Device: Medtronic LINQIIPatients undergoing a deep brain stimulation procedure will have the LINQII device implanted temporarily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic LINQIIBilateral LINQII devices will be implanted under the scalp during surgery to obtain approximately 30 minutes of brain signal recordings. | Device | Deep Brain Stimulation Patients, Stereo-electrode (SEEG) Patients |
Primary outcome
Total number of recordings obtained
Time frame: Baseline
Number of subjects to have brain signal recordings obtained by the LINQII device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathon J. Parker, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic LINQII in people with Cranial Neurosurgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of recordings obtained (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.