PRIME: PReservIng Memory in Epilepsy

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Nitin Tandon
Study ID
NCT05608408
Status
Recruiting
Apply to this trial

Conditions

  • Mesial Temporal Lobe Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system — DEVICE
    Stimulation of site with the Medtronic Percept PC system using low frequency stimulation at 0.5 Hz.
  • Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system — DEVICE
    Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system using standard of care high frequency stimulation parameters.

Study Details

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.

Key Dates

Start date
Nov 16, 2023
Status verified
Apr 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 1
  • Experimental: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 2
  • Experimental: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 3
  • Experimental: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 4

Primary Outcome Measure

Number of seizures as self-reported by participants [ Time Frame: baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Gregory Worrell, MD, PhD
[email protected]
The University of Texas Science Center at HoustonHoustonTexas77030
Jessica Johnson, MSN, NP-C
[email protected]
713-500-5443
Eliana Klier, PhD
[email protected]
713-500-5442

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By research site
Mayo Clinic· Rochester, MNThe University of Texas Science Center at Houston· Houston, TX

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