Is NCT07012148 recruiting in Rochester, MN?

Yes, NCT07012148 is currently recruiting participants at its Rochester, MN location. This focal epilepsy clinical trial is actively enrolling qualified participants.

How do I join the focal epilepsy clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Focal Epilepsy Clinical Trial in Rochester, MN

Who Can Participate

Inclusion Criteria

Subjects enrolled in this study must have epilepsy involving the temporal lobe and will have undergone video-EEG monitoring within the past 3 years, and will have met the following criteria:

Focal epilepsy, including complex partial, and secondarily generalized seizures, including:

disabling seizure (i.e. involving loss of awareness, motor control, speech, or other essential functions) counts at least 2 per month on average over the preceding 3 months, established by verbal history or caregiver report.

For 3 months prior to enrollment, subject's AED dosages have been stable (less than a 25% change in dosage) and subject has had at least two seizures per month, on average, with a seizure-free interval not to exceed 60 days. Seizures must be separated by a minimum of four hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.

With the exception of epilepsy, subject must be medically and neurologically stable.

Age 18 to 75.

Ability and willingness to provide informed consent and participate in the study protocol. Subject is able to interpret and to respond, in accordance with the study protocol, to the advisory indicators provided by the device.

Subject has seizures that are distinct, stereotypical events that can be reliably counted by the subject or caregiver, and have a distinct EEG pattern that can be recorded using subscalp EEG over the frontotemporal head region, established by video-EEG monitoring.

Subject can reasonably be expected to maintain a seizure diary alone or with the assistance of a competent individual.

Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.

Subject's seizure focus, based upon clinical semiology, scalp EEG, intracranial electroencephalographic (iEEG) findings, and/or neuroimaging, demonstrate consistent involvement of the temporal lobe with their EEG seizure pattern.

Subject speaks and reads English.

Subject has no reason to anticipate requiring a magnetic resonance imaging (MRI) evaluation within the next two years.

Subject has EEG documentation of ictal events consistent with his or her predominant current seizure type.

Subject's anatomy will permit implantation of the UNEEG SubQ device in the opinion of the study's neurosurgeon.

Female subjects have a negative pregnancy test, have no plans to become pregnant, and use effective contraception during the study.

Exclusion Criteria

For 3 months prior to enrollment, subject's AED dosages have not been stable (greater than 25% change in dosage), or subject has had more than 30 disabling seizures per month, on average, or more than 10 seizure days per month, on average.

Subject needs to have magnetic resonance imaging during the study period.

Subject has a substance abuse history (alcohol, prescription, or illicit medications) within the preceding two years.

Subject participated in another drug or device trial within the preceding 30 days.

Subject has been hospitalized for a psychiatric condition within the preceding two years or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).

Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, brain stimulator, or other medical device that would interfere with the UNEEG device. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, and cochlear implants. Vagus nerve stimulators are not expected to interfere with the subscalp EEG device and will be permitted, as long as stimulation parameters can be reasonably expected to remain stable (25% or less change in amplitude) throughout the study.

Subject has experienced unprovoked status epilepticus.

Subject has had therapeutic surgery to treat epilepsy that may interfere with electrode placement in the judgement of the neurosurgeon.

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). If platelet dysfunction is suspected, subject can be enrolled only if a hematologist, the Investigator, and the neurosurgeon judge it to be advisable. Blood tests to evaluate platelet and bleeding disorder issues will be obtained prior to enrollment.

Subject is otherwise ineligible for cranial surgery, or the Investigators identify other medical or psychosocial factors that would counter indicate participation in the study.

Subject is pregnant or intends to become pregnant during the study period.

Subject has a known diagnosis of psychogenic nonepileptic seizures (PNES)

Female subject is pregnant or plans to become pregnant.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT07012148) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Focal Epilepsy Treatment Options in Rochester, MN

If you're searching for focal epilepsy treatment options in Rochester, MN, this clinical trial (NCT07012148) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced focal epilepsy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all focal epilepsy clinical trials near you to find additional studies recruiting in your area.

Focal Epilepsy Clinical Trial in Rochester, MN

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