PRIME: PReservIng Memory in Epilepsy
Network Neuro-modulation for Mesial Temporal Lobe Epilepsy
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
A observational or N/A phase clinical study on Mesial Temporal Lobe Epilepsy, this trial is actively recruiting participants. The trial is conducted by National Institute of Neurological Disorders and Stroke (NINDS) and has accumulated 10 data snapshots since 2023. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Different stimulation types will be administered in a crossover fashion, as follows. There will be four four-month periods of low-frequency DBS stimulation, and in each of these four-month periods, stimulation will occur at one of four different sites \[the anterior nucleus of the thalamus (ANT), entorhinal cortex (ERC), piriform cortex (PiC), and hippocampal fornix (HCF)\], with the order of receipt differing among study participants. There will be a 3-month washout period after each 4-month stimulation period, with the washout being standard of care (SOC) high-frequency DBS stimulation of the ANT. Finally, there will be a 7 to 12 month DBS stimulation period with the stimulation type that yielded the best results.
Different stimulation types will be administered in a crossover fashion, as follows. There will be four four-month periods of low-frequency DBS stimulation, and in each of these four-month periods, stimulation will occur at one of four different sites \[the anterior nucleus of the thalamus (ANT), entorhinal cortex (ERC), piriform cortex (PiC), and hippocampal fornix (HCF)\], with the order of receipt differing among study participants. There will be a 3-month washout period after each 4-month stimulation period, with the washout being standard of care (SOC) high-frequency DBS stimulation of the ANT. Finally, there will be a 7 to 12 month DBS stimulation period with the stimulation type that yielded the best results.
Status Flow
Change History
10 versions recorded-
Apr 28, 2026 — Present [daily]
Recruiting
Phase: NA → None
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Jan 2025 — Apr 2026 [monthly]
Recruiting NA
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Sep 2024 — Jan 2025 [monthly]
Recruiting NA
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Jul 2024 — Sep 2024 [monthly]
Recruiting NA
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Apr 2024 — Jul 2024 [monthly]
Recruiting NA
▶ Show 5 earlier versions
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Mar 2024 — Apr 2024 [monthly]
Recruiting NA
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Jan 2024 — Mar 2024 [monthly]
Recruiting NA
Status: Not Yet Recruiting → Recruiting
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Jun 2023 — Jan 2024 [monthly]
Not Yet Recruiting NA
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Apr 2023 — Jun 2023 [monthly]
Not Yet Recruiting NA
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Dec 2022 — Apr 2023 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility 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.
Contact Information
- National Institute of Neurological Disorders and Stroke (NINDS)
- Nitin Tandon
For direct contact, visit the study record on ClinicalTrials.gov .