Intracranial Stimulation Mapping In Epilepsy

NCT05290610 | Recruiting

• 1 other identifier: PSYCH-2021-30271
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Research IESM

OTHER

Functional mapping for research application

Other: Functional mapping

Interventions

Functional mapping OTHER

Intracranial EEG data acquisition, observation and behavioral testing, and intracranial electrical stimulation

Research IESM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Brain Mapping

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Functional Neuroimaging; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Alexander Herman, MD

  UMN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Maple

CONTACT

612-946-1424; maple036@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group prospective feasibility study on adult epilepsy patients evaluating whether study tasks and workflow are feasible

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: March 22, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)