Brain pacemaker aims to quiet seizures and boost memory
NCT ID NCT05608408
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a personalized deep brain stimulation (DBS) method for people with epilepsy that starts in the memory center of the brain. Eight participants will receive a device that sends low-frequency electrical pulses to specific brain networks, with the goal of reducing seizures and improving memory. The approach uses recordings from inside the brain to tailor stimulation to each person's unique wiring.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with a presumptive diagnosis of EPH determined by the group of clinicians who participate in patient management conference. * Ability to comply with test directions and provide informed consent or assent to the study, i.e. cognitively able to participate in studies \[typically intelligence quotient (IQ) of 65 or above\]. * Relatively preserved verbal memory - as determined via formal neuropsychological evaluation performed by the neuropsychologist. The values must within 1.5 standard deviation (SD) of the mean for verbal memory * Proficient in English, as all of our tasks and consent forms will be in English and the inclusion of non-English speakers will introduce another confound in this small sample size and preclude grouped analysis * Age 18 - 65 years (we expect the trial to take 5 years and wish to target patients with minimal medical co-morbidities) * Must have a minimum of 2 seizures of any type per month - this is essential to be able to detect the impact of neuromodulation on the epilepsy over relatively short intervals of time. Patients with secondary generalized seizures may also be enrolled so long as they have a maximum of 20 generalized seizures in the past 12 months (prior to enrollment), or an average of no more than 3 generalized seizures per month. Exclusion Criteria: * Impaired reading and cognitive functions (more than 3 standard deviations below the mean, usually an IQ \< 60), as determined by preoperative neuropsychological testing. * Patients with gross structural abnormalities (hamartomata, tumors, vascular malformations, diffuse malformations of cortical development) in the brain that raise the possibility of dual pathology resulting in the epilepsy and by derivation, a larger epilepsy network. * Patients with neurological conditions such as recent history (within past 5 years) of a stroke, encephalitis and meningitis. Any patient with a current diagnosis of these conditions will also be excluded. * Patients with any episodes of status epilepticus in the past 12 months prior to enrollment. * Patients with uncontrolled prominent psychiatric comorbidity that will preclude their meaningful participation. * Patients with a Beck Depression Inventory II score at baseline examination greater than or equal to 29 (i.e., severe depression). * Patients who have attempted suicide in the past 12 months. * Patients with memory impairment due to other neurological conditions such as dementia and Parkinson's disease. * Patients who are unable to speak or comprehend English. The inclusion of multiple languages will make task development and grouped comparisons of neuro-psychology data difficult. * Patients with cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices that are deemed MRI incompatible by the manufactures. The absence of high resolution structural imaging precludes appropriate targeting of the regions of interest. * Profound hippocampal sclerosis with prominent atrophy of the majority of the hippocampus (equivalent to ILAE type III). * Prior brain surgery for any reason or failed prior brain neuromodulation \[prior vagus nerve stimulation (VNS) therapy is acceptable so long as it is held constant for the duration of the trial\]. * History of or current non-epileptic spells (will confound accuracy of seizure detection with ANT Percept PC and the precision of the estimate of the neuromodulation effect). * Patients who are pregnant. All female participants of childbearing potential will be counselled prior to enrollment regarding the unknown risks of treatment on a fetus and the importance of using contraception while they are a subject in this study. If a female participant becomes pregnant during the study, they will returned to FDA-approved ANT stimulation parameters (standard of care).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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The University of Texas Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States
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