EpilepsyNCT05290610
Intracranial Stimulation Mapping In Epilepsy
A study testing Functional mapping in people with Epilepsy, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Functional mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Alexander Herman, MD, PhD, 612-625-1194, herma686@umn.edu
About this study
Official title: Intracranial Stimulation Mapping In Epilepsy -The InStim Study
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
- Being tested
- Functional mapping
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional mappingOther
Intracranial EEG data acquisition, observation and behavioral testing, and intracranial electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Research IESM | Other | Functional mapping for research application Receives: Other: Functional mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after stimulation sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Herman, MD, Principal investigator, UMN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290610
- Sponsor's protocol ID
- PSYCH-2021-30271
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Stimulation Mapping In Epilepsy -The InStim Study
- ClinicalTrials.gov ID
- NCT05290610
- Acronym / sponsor ID
- PSYCH-2021-30271
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group prospective feasibility study on adult epilepsy patients evaluating whether study tasks and workflow are feasible
| Arm | Type | Receives |
|---|---|---|
| Research IESM | Other | Other: Functional mappingFunctional mapping for research application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional mappingIntracranial EEG data acquisition, observation and behavioral testing, and intracranial electrical stimulation | Other | Research IESM |
Primary outcome
The effect of prefrontal direct electrical brain stimulation on cognitive effort
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Herman, MD principal investigator
UMN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional mapping in people with Epilepsy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Maple (612-946-1424, maple036@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of prefrontal direct electrical brain stimulation on cognitive effort (time frame: Immediately after stimulation sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.