Intracranial Stimulation Mapping In Epilepsy | NCT05290610

Studies
Intracranial Stimulation Mapping In Epilepsy

NCT05290610

Sponsor

University of Minnesota

Status

Recruiting

Last Update Posted

Apr 9, 2026Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Epilepsy

Interventions

Functional mapping

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Jun 1, 2027Estimated

Completion Date

Sep 1, 2027Estimated

First Submitted Date

Jan 21, 2022

First Submission Date that Met QC Criteria

Mar 11, 2022

First Posted Date

Mar 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2026

Last Update Posted Date

Apr 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single group prospective study to determine the feasibility for generating brain maps that localize cerebral functions and inter-regional information flow in partial epilepsy in adult patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Research IESM	Other	Functional mapping for research application	Other: Functional mapping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Functional mapping	Other	Intracranial EEG data acquisition, observation and behavioral testing, and intracranial electrical stimulation	Research IESM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effect of prefrontal direct electrical brain stimulation on cognitive effort	The change in subjective value of cognitive effort (area under the curve) after direct electrical brain stimulation to different areas of the prefrontal cortex during an effortful task	Immediately after stimulation sessions

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 18 years and older at screening.
Written informed consent is obtained from the participant to comply with the requirements of the study.
Stated willingness to comply with all study procedures and availability for the duration of the study
Currently undergoing clinically indicated intracranial EEG monitoring for planning of epilepsy surgery in the University of Minnesota/MINCEP program.

Exclusion Criteria:

Pregnancy ruled out prior to approval for intracranial EG monitoring.
Persons who are rendered temporarily or permanently invulnerable by inability to understand the research due to study complexity, cognitive impairment, or by inability to make independent decisions owing to University of Minnesota or to Fairview health services.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew Maple	Contact	612-946-1424		maple036@umn.edu

Overall Officials

Name	Affiliation	Role
Alexander Herman, MD	UMN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota	Recruiting	Minneapolis	Minnesota	55455	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Feb 1, 2022	Oct 19, 2022	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001931	Brain Mapping

Ancestor Terms

ID	Term
D059907	Functional Neuroimaging
D059906	Neuroimaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided