RESTORE: Restoring State-dependent Thalamocortical Oscillations in Epilepsy

Trial details

Who runs it

Gregory Worrell

Trial code

NCT07927985

Record updated

10 November 2026

Original description

The purpose of this research study is to determine the safety and effectiveness of the investigational Cadence Biomarker Targeted Stimulation (BTS) System (Model 5100 EEG Workstation and Alera Model 2000 Biomarker Stimulation System), when used to reduce the frequency of seizures in patients with generalized onset epilepsy.Read full original descriptionShow less

The purpose of this research study is to determine the safety and effectiveness of the investigational Cadence Biomarker Targeted Stimulation (BTS) System (Model 5100 EEG Workstation and Alera Model 2000 Biomarker Stimulation System), when used to reduce the frequency of seizures in patients with generalized onset epilepsy.

Inclusion: Generalized-onset seizures; Failure of at least two appropriately selected and adequately dosed anti-seizure medications; Distinct, stereotyped seizures that the participant or caregiver can reliably count; Ability, independently or with a competent assistant, to maintain a seizure diary and use the BTS System; Stable anti-seizure medication doses and ketogenic diet, if applicable, for 1 month before enrollment, except acute intermittent benzodiazepine use; At least 3 disabling seizures per month on average. Seizures separated by less than 8 hours are counted as one cluster for this criterion; Ability to complete required office and telephone or video visits; For participants of childbearing potential: negative serum pregnancy test within 2 weeks before implantation and use of reliable contraception, surgical sterility, or at least 2 years postmenopausal; Informed of reasonable alternatives, including surgery, other devices, medication, and dietary options; Adequate epilepsy-protocol brain MRI within the previous 2 years; Anatomy permits implantation of the INSR within 20 mm of the skin surface.

Exclusion: Substance abuse within the previous 2 years; Participation within the previous 30 days in another drug or device study that may confound results; Anatomy that the surgical team determines may preclude safe electrode implantation; Active psychosis, major depression, or suicidal ideation within the previous 6 months; Unprovoked convulsive status epilepticus within the previous year, defined as a tonic-clonic seizure lasting at least 5 minutes or repeated tonic-clonic seizures without recovery of consciousness for more than 5 minutes; Implanted pacemaker, implantable cardioverter-defibrillator, cardiac management product, vagus nerve stimulator, or other medical device that interferes with the BTS System or is affected by it; Psychogenic or nonepileptic seizures that cannot be distinguished from epileptic events; Ineligibility for cranial surgery or a medically or neurologically unstable condition, including brain tumor, multiple sclerosis, dementia, or intracranial vascular lesion; Significant platelet dysfunction due to a medical condition or medication unless a hematologist, investigator, and neurosurgeon agree enrollment is advisable; Use of anticoagulants that cannot be discontinued perioperatively as required; Participant or legally authorized representative cannot demonstrate ability to provide valid informed consent in accordance with regulatory requirements; In the investigator's opinion, the individual is a poor candidate for the study.

ClinicalTrials.gov NCT07927985