| NCT ID | NCT07110337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Epiminder America, Inc. |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-12-23 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2025-12-23 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends. All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of focal and/or generalized epilepsy. * Drug-resistant * At least an average of 1 seizure within the past 3 months * Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring. Exclusion Criteria: * Epilepsy surgery within the past 6 months * Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS) * Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy * Participant cannot have surgery to have the device implanted
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07110337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07110337 currently recruiting?
Yes, NCT07110337 is actively recruiting participants. Contact the research team at clinical@epiminder.com for enrollment information.
Where is the NCT07110337 trial being conducted?
This trial is being conducted at Phoenix, United States, Irvine, United States, Palo Alto, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT07110337 clinical trial?
NCT07110337 is sponsored by Epiminder America, Inc.. The trial plans to enroll 210 participants.
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