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Intracranial Stimulation Mapping In Epilepsy

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional mapping
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Research IESM

Arm Description

Functional mapping for research application

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
June 21, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05290610
Brief Title
Intracranial Stimulation Mapping In Epilepsy
Official Title
Intracranial Stimulation Mapping In Epilepsy -The InStim Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single group prospective feasibility study on adult epilepsy patients evaluating whether study tasks and workflow are feasible
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Research IESM
Arm Type
Other
Arm Description
Functional mapping for research application
Intervention Type
Other
Intervention Name(s)
Functional mapping
Intervention Description
Intracranial EEG data acquisition, observation and behavioral testing, and intracranial electrical stimulation
Primary Outcome Measure Information:
Title
The effect of prefrontal direct electrical brain stimulation on cognitive effort
Description
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
Time Frame
Immediately after stimulation sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Maple
Phone
612-946-1424
Email
maple036@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Herman, MD
Organizational Affiliation
UMN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Herman, MD, PhD
Phone
612-625-1194
Email
herma686@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Intracranial Stimulation Mapping In Epilepsy

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