Clinical trial for Epilepsy
Official title Biomarker Targeted Stimulation for Epileptiform Events
ClinicalTrials.gov ID: NCT06424977
What this study is testing
- What it's testing
- This is a controlled study designed to look at treatment with the BTS System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 and older, men only
You may be able to join if
- Subject is greater than or equal to 7 years of age.
- Subject has focal onset seizures.
- Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
- Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver.
- Subject can reasonably be expected to maintain a seizure diary and the BTS System alone, or with the assistance of a competent individual.
You likely can't join if
- Subject has a history of substance abuse within the preceding two years.
- Subject participated in another drug or device trial that may confound study results within the preceding 30 days.
- Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the BTS...
- Subject has anatomy that may interfere with electrode placement.
- Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.
- Subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate).
See the full eligibility criteria
- Subject is greater than or equal to 7 years of age.
- Subject has focal onset seizures.
- Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
- Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver.
- Subject can reasonably be expected to maintain a seizure diary and the BTS System alone, or with the assistance of a competent individual.
- For one month prior to enrollment, subject's anti-epileptic medication dosages and ketogenic diet (as applicable) have been stable (other than acute, intermittent use of benzodiazepines) and subject has had at least...
- Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.
- A female subject of childbearing age must have a negative serum pregnancy test within two weeks prior to implant of the INSR, and, if sexually active, must be using a reliable form of birth control, be surgically...
- Subject has been informed of their eligibility for resective surgery as a potential alternative to the study, if such surgery is a reasonable option.
- Subject has had a brain MRI epilepsy evaluation within the past two years.
- Subject's anatomy will permit implantation of the INSR within 20 mm of the skin surface.
- Subject has a history of substance abuse within the preceding two years.
- Subject participated in another drug or device trial that may confound study results within the preceding 30 days.
- Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the BTS System or with which the BTS System interferes.
- Subject has anatomy that may interfere with electrode placement.
- Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.
- Subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate).
- Subject has been diagnosed with psychogenic or non-epileptic seizures that cannot be distinguished from their epileptogenic events.
- Subject is ineligible for cranial surgery or has medical and/or neurologically unstable condition (e.g brain tumor, multiple sclerosis, dementia, or intracranial vascular lesion).
- Subject has been diagnosed with active psychosis, major depression, or suicidal ideation in the preceding 6 months.
- Subject has primary generalized seizures.
- The active part of a tonic-clonic seizure lasts 5 minutes or longer, or
- Repeated tonic-clonic seizures without recovering consciousness for a period of longer than 5 minutes
- Subject, in the opinion of the Investigator, would be a poor study candidate.
The study team makes the final eligibility decision.
Where it is enrolling
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 7 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.