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RECRUITING NA

PRIME: PReservIng Memory in Epilepsy

NCT05608408 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • 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

Study Locations (2)

Minnesota

  • Mayo Clinic — Rochester

Texas

  • The University of Texas Science Center at Houston — Houston

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2023-11-16
Est. Completion 2028-03-31
Phase NA

Sponsor

Nitin Tandon

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05608408

The ClinicalTrials.gov registry entry for NCT05608408 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nitin Tandon, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Mesial Temporal Lobe Epilepsy appearing as the primary indexed condition, and to 2 interventions — of which Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05608408 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Minnesota, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05608408 about?

NCT05608408 is a clinical study titled "PRIME: PReservIng Memory in Epilepsy". 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) Neurostimul...

What is the current status of trial NCT05608408?

This trial is currently recruiting. It is a NA study. The enrollment target is 8 participants. The study started on 2023-11-16. Estimated completion is 2028-03-31.

What conditions does trial NCT05608408 study?

This clinical trial studies the following conditions: Mesial Temporal Lobe Epilepsy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05608408?

The interventions under investigation include: 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 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05608408?

This trial is sponsored by Nitin Tandon, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05608408 being conducted?

This trial has 2 study locations across Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial