Intracranial Stimulation Mapping In Epilepsy

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT05290610

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Other: Functional mapping	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Intracranial Stimulation Mapping In Epilepsy -The InStim Study

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Research IESM Functional mapping for research application	Other: Functional mapping Intracranial EEG data acquisition, observation and behavioral testing, and intracranial electrical stimulation

Arm

Intervention/Treatment

Other: Research IESM

Functional mapping for research application

Other: Functional mapping

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

Outcome Measures

Primary Outcome Measures

The effect of prefrontal direct electrical brain stimulation on cognitive effort [Immediately after stimulation sessions]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: Alexander Herman, MD, UMN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT05290610

Other Study ID Numbers:

PSYCH-2021-30271

First Posted:

Mar 22, 2022

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Epilepsy

Study Results

No Results Posted as of Jul 8, 2022