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New treatment option for Mesial Temporal Lobe Epilepsy
Official title PRIME: PReservIng Memory in Epilepsy
ClinicalTrials.gov ID: NCT05608408
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Relatively preserved verbal memory - as determined via formal neuropsychological evaluation performed by the neuropsychologist. The values must...
- 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...
- Age 18 - 65 years (we expect the trial to take 5 years and wish to target patients with minimal medical co-morbidities)
You likely can't join if
- Impaired reading and cognitive functions (more than 3 standard deviations below the mean, usually an IQ \< 60), as determined by preoperative...
- Patients with gross structural abnormalities (hamartomata, tumors, vascular malformations, diffuse malformations of cortical development) in the...
- Patients with neurological conditions such as recent history (within past 5 years) of a stroke, encephalitis and meningitis. Any patient with a...
- 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).
See the full eligibility criteria
Who can join
- 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...
What rules you out
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.