Actively Recruiting
PRIME: PReservIng Memory in Epilepsy
Led by Nitin Tandon · Updated on 2026-04-27
8
Participants Needed
2
Research Sites
280 weeks
Total Duration
On this page
Sponsors
N
Nitin Tandon
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRIME: PReservIng Memory in Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a presumptive diagnosis of epilepsy in a preserved hippocampus as determined by clinicians
- Ability to comply with study directions and provide informed consent, typically an IQ of 65 or above
- Verbal memory within 1.5 standard deviations of the mean based on neuropsychological evaluation
- Proficient in English for study tasks and consent
- Age between 18 and 65 years
- At least 2 seizures of any type per month; if secondary generalized seizures occur, no more than 20 generalized seizures in the past 12 months or an average of no more than 3 generalized seizures per month
You will not qualify if you...
- Impaired reading and cognitive function more than 3 standard deviations below the mean (usually IQ below 60)
- Gross structural brain abnormalities such as tumors, vascular malformations, or diffuse malformations of cortical development
- Neurological conditions including recent stroke, encephalitis, or meningitis within the past 5 years or current diagnosis
- Any episodes of status epilepticus in the past 12 months
- Uncontrolled significant psychiatric conditions preventing meaningful participation
- Beck Depression Inventory II score of 29 or higher (severe depression)
- Suicide attempt within the past 12 months
- Memory impairment due to other neurological diseases such as dementia or Parkinson's disease
- Inability to speak or understand English
- Presence of MRI-incompatible implanted metallic devices like cardiac pacemakers or aneurysm clips
- Severe hippocampal sclerosis with prominent atrophy of most of the hippocampus
- Prior brain surgery or failed brain neuromodulation, except stable prior vagus nerve stimulation
- History or current presence of non-epileptic spells
- Pregnancy; female participants of childbearing potential must use contraception and will be returned to standard care if pregnant during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
The University of Texas Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nitin Tandon, MD
CONTACT
E
Eliana M Klier, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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