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NCT05608408 · ClinicalTrials.gov registry record · NA
PRIME: PReservIng Memory in Epilepsy
A NA study of Mesial Temporal Lobe Epilepsy, sponsored by Nitin Tandon.
- Recruiting
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 2
- Study locations
NCT05608408 is a NA study of Mesial Temporal Lobe Epilepsy that is actively recruiting participants, run by Nitin Tandon. The registered enrollment target is 8 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT05608408, a NA study of Mesial Temporal Lobe Epilepsy, is actively recruiting participants, sponsored by Nitin Tandon.
- RECRUITING
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 2
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-11-16 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. 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.
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.
NCT05608408 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Texas.
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.
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).
Who is sponsoring clinical trial NCT05608408?
This trial is sponsored by Nitin Tandon, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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