RecruitingNot ApplicableNCT05608408

PRIME: PReservIng Memory in Epilepsy

Network Neuro-modulation for Mesial Temporal Lobe Epilepsy


Sponsor

Nitin Tandon

Enrollment

8 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system and a medical device called Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system for people with mesial temporal lobe epilepsy. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELow Frequency Stimulation (LFS) of site with the Medtronic Percept PC system

Stimulation of site with the Medtronic Percept PC system using low frequency stimulation at 0.5 Hz.

DEVICEStandard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system

Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system using standard of care high frequency stimulation parameters.


Locations(2)

Mayo Clinic

Rochester, Minnesota, United States

The University of Texas Science Center at Houston

Houston, Texas, United States

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NCT05608408


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