PRIME: PReservIng Memory in Epilepsy

Launched by NITIN TANDON · Nov 1, 2022

Keywords

ClinConnect Summary

The PRIME trial is studying a new treatment option for patients with mesial temporal lobe epilepsy, a type of epilepsy that can affect memory. In this study, participants will receive a special type of brain stimulation called Deep Brain Stimulation (DBS). This method uses a device to send low-frequency electrical signals to the brain, aiming to reduce the number and severity of seizures and potentially improve memory function. The researchers believe that this targeted stimulation can help patients with epilepsy that affects the hippocampus, a part of the brain linked to memory.

To join the study, participants need to be between 18 and 65 years old and have a confirmed diagnosis of epilepsy. They should have at least two seizures each month and a relatively preserved verbal memory, meaning their memory skills are close to average. Participants will undergo evaluations to ensure they can understand the study and follow directions. Throughout the trial, they will be closely monitored for changes in seizure frequency and memory. It's important to know that certain conditions, like severe depression or other neurological disorders, may exclude someone from participating. The study aims to provide insights into how this innovative treatment can help improve the lives of those living with epilepsy.

Gender

ALL

Eligibility criteria

• 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).