PRIME: PReservIng Memory in Epilepsy

NCT05608408 | Recruiting DMC FDA Device

• 2 other identifiers: HSC-MS-22-01361UH3NS119834
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mesial Temporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (15)

• Number of seizures as self-reported by participants

  baseline

• Number of seizures as self-reported by participants

  2 weeks

• Number of seizures as self-reported by participants

  4 weeks

• Number of seizures as self-reported by participants

  6 weeks

• Number of seizures as self-reported by participants

  8 weeks

• Number of seizures as self-reported by participants

  10 weeks

• Number of seizures as self-reported by participants

  12 weeks

• Number of seizures as self-reported by participants

  14 weeks

• Number of seizures as self-reported by participants

  16 weeks

• Number of seizures as assessed by EEG

  baseline

• Number of seizures as assessed by EEG

  4 months

• Number of seizures as assessed by the Percept PC

  baseline

• Number of seizures as assessed by the Percept PC

  4 months

• Number of inter-ictal spikes as assessed by the Percept PC

  baseline

• Number of inter-ictal spikes as assessed by the Percept PC

  4 months

Secondary Outcomes (8)

• Verbal memory as assessed by score on the California Verbal Learning Test second edition

  baseline

• Verbal memory as assessed by score on the California Verbal Learning Test second edition

  4 months

• Verbal memory as assessed by score on the Logical Memory I and II subtests from the Wechsler Memory Scale - IV

  baseline

• Verbal memory as assessed by score on the Logical Memory I and II subtests from the Wechsler Memory Scale - IV

  4 months

• Wellness as assessed by score on the the Quality of Life in Epilepsy 31 (QOLIE-31) survey

  baseline

Study Arms (4)

Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 1

EXPERIMENTAL

Device: Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system; Device: Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system

Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 2

EXPERIMENTAL

Device: Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system; Device: Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system

Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 3

EXPERIMENTAL

Device: Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system; Device: Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system

Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 4

EXPERIMENTAL

Device: Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system; Device: Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system

Interventions

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.

Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 1; Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 2; Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 3; Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 4

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.

Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 1; Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 2; Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 3; Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 \[typically intelligence quotient (IQ) of 65 or above\].
• 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
• 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 seizures may also be enrolled so long as they have a maximum of 20 generalized seizures in the past 12 months (prior to enrollment), or an average of no more than 3 generalized seizures per month.

You may not qualify if:

• 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 epilepsy and by derivation, a larger epilepsy network.
• 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 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 imaging precludes appropriate targeting of the regions of interest.
• 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 they are a subject in this study. If a female participant becomes pregnant during the study, they will returned to FDA-approved ANT stimulation parameters (standard of care).

Sponsors & Collaborators

• Nitin Tandon: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

The University of Texas Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Nitin Tandon, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Tandon, MD

CONTACT

713-500-5443; Nitin.Tandon@uth.tmc.edu

Eliana M Klier, PhD

CONTACT

713-500-5442; Eliana.Klier@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: November 16, 2023
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)