Intracranial Stimulation Mapping In Epilepsy

NCT ID: NCT05290610

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2026-09-01

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single group prospective feasibility study on adult epilepsy patients evaluating whether study tasks and workflow are feasible
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Research IESM

Functional mapping for research application

Group Type OTHER

Functional mapping

Intervention Type OTHER

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

Interventions

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Functional mapping

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Herman, MD

Role: PRINCIPAL_INVESTIGATOR

UMN

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew Maple

Role: CONTACT

612-946-1424

Facility Contacts

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Alexander Herman, MD, PhD

Role: primary

612-625-1194

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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PSYCH-2021-30271

Identifier Type: -

Identifier Source: org_study_id

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