A Prospective Study to Evaluate the Use of the Minder Device to Aid in Developing a Treatment Plan After Inconclusive Prolonged EEG in Patients With Epilepsy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Epiminder, Director of Clinical Trials
clinical@epiminder.com
800-717-3185
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2027-06
Participants
Target number of participants: 210
Treatments
Experimental: Minder System Treatment Arm
Placebo_comparator: Minder System Control Arm
No_intervention: Standard of Care Arm
Related Therapeutic Areas
Sponsors
Leads: Epiminder America, Inc.

This content was sourced from clinicaltrials.gov