Intracranial Stimulation Mapping In Epilepsy

Epilepsy Clinical Trial

Official title:

Intracranial Stimulation Mapping In Epilepsy -The InStim Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290610
• Other study ID #: PSYCH-2021-30271
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2023
• Source: University of Minnesota
• Contact: Matthew Maple
• Phone: 612-946-1424
• Email: maple036[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Functional mapping
Intracranial EEG data acquisition, observation and behavioral testing, and intracranial electrical stimulation

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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