Clinical Trials

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 IQ of 65 or above).
• Relatively preserved verbal memory – as determined via formal neuropsychological evaluation performed by the neuropsychologist. The values must within 1 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 comorbidities).
• Must have a minimum of 2 seizures per month - this is essential to be able to detect the impact of neuromodulation on the epilepsy over relatively short intervals of time.

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 uncontrolled prominent psychiatric comorbidity that will preclude their meaningful participation.
• 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.
• Classic hippocampal sclerosis (equivalent to ILAE type 1) by imaging.
• Prior brain surgery for any reason or failed prior brain neuromodulation (prior 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. 

Eligibility last updated 8/26/22. Questions regarding updates should be directed to the study team contact.