Intractable EpilepsyNCT07014592
Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable Epilepsy
A study testing stimulating probes and electrodes in people with Intractable Epilepsy, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this project is to study how the brain reacts to a small electrical signal. Researchers will be using a novel combination of recording electrodes. The researchers will measure the brain response from these electrodes. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Intractable Epilepsy
- What is being tested?
- stimulating probes and electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to Jun 2028
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with medication intractable epilepsy who are recommended to undergo brain surgery to remove a "seizure" focus
- Can provide informed consent for the study and willing to participate
Who cannot join
- Presence of a permanent electronic implant
- Any chronic medical conditions that prevent safe placement of electrodes
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 Michigan
Ann Arbor, Michigan, 48109
Ron Ball, 734-936-7010, rmball@umich.edu
Matthew Willsey, MD, PhD
About this study
The goal of this project is to study how the brain reacts to a small electrical signal. Researchers will be using a novel combination of recording electrodes. The researchers will measure the brain response from these electrodes.
- Conditions
- Intractable Epilepsy
- Being tested
- stimulating probes and electrodes
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulating probes and electrodesDevice
Subdural electrodes and/or ball tip probes will be used intraoperatively to provide electrical stimulation to the brain.
| Study group | Role | What they receive |
|---|---|---|
| Medication-intractable epilepsy | Experimental | Not described Receives: Device: stimulating probes and electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of time-frequency data
From recording electrodes
Measured: During a 20 minute research phase of a clinically indicated surgery
Characterization of local field responses (LFPs)
From recording electrodes
Measured: During a 20 minute research phase of a clinically indicated surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start5 May 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable EpilepsyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew S Willsey, University of Michigan
- Investigators
- Matthew Willsey, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014592
- Sponsor's protocol ID
- HUM00258281
- Status last verified
- Jun 2026
- First submitted
- 24 May 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The aspects of a plan for sharing are still under determination.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable Epilepsy
- ClinicalTrials.gov ID
- NCT07014592
- Acronym / sponsor ID
- HUM00258281
- Conditions
- Intractable Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Jun 2025 (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.
The goal of this project is to study how the brain reacts to a small electrical signal. Researchers will be using a novel combination of recording electrodes. The researchers will measure the brain response from these electrodes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication-intractable epilepsy | Experimental | Device: stimulating probes and electrodes |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with medication intractable epilepsy who are recommended to undergo brain surgery to remove a "seizure" focus
- Can provide informed consent for the study and willing to participate
Key exclusion criteria (2 listed)
- Presence of a permanent electronic implant
- Any chronic medical conditions that prevent safe placement of electrodes
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 |
|---|---|---|
| stimulating probes and electrodesSubdural electrodes and/or ball tip probes will be used intraoperatively to provide electrical stimulation to the brain. | Device | Medication-intractable epilepsy |
Primary outcome
Characterization of time-frequency data
Time frame: During a 20 minute research phase of a clinically indicated surgery
From recording electrodes
Characterization of local field responses (LFPs)
Time frame: During a 20 minute research phase of a clinically indicated surgery
From recording electrodes
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 8 Jun 2026.
- Individual participant dataSharing planned: No. The aspects of a plan for sharing are still under determination.
Related trials for Intractable Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Recruiting
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
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.
Matthew Willsey, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stimulating probes and electrodes in people with Intractable Epilepsy, run by University of Michigan 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 2 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 8 Jun 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 Ron Ball (734 936-7010, rmball@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of time-frequency data (time frame: During a 20 minute research phase of a clinically indicated surgery). The study lists 2 primary outcomes in all. 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 8 Jun 2026.