PRIME: PReservIng Memory in Epilepsy
ConditionMesial Temporal Lobe Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNitin Tandon
About this trial
In this study, participants will receive unilateral Deep Brain Stimulation (DBS) for treatment of epilepsy, with network-based stimulation targets specifically defined using a stereo-electro-encephalographic evaluation and chronic recordings using the Medtronic Percept™ primary cell (PC) Neurostimulator DBS System with BrainSense™ Technology. The hypothesis is that, compared to no stimulation or to standard duty cycle high frequency stimulation, epilepsy neuromodulation using low frequency stimulation and informed by network architecture in patients with epilepsy that arises in a hippocampus that also subserves memory - epilepsy in a precious hippocampus (EPH) - will result in a significant decrease in seizure frequency and severity, paralleled by a decrease in EEG spike counts and improved memory function.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system
- Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system
Treatment groups
8 Participants
are divided into 4 treatment groupsSponsors and collaborators
Nitin Tandon
Lead sponsor
The University of Texas Health Science Center, Houston
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov