Network Neuro-modulation for Mesial Temporal Lobe Epilepsy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• Proficient in English, as all of our tasks and consent forms will be in English and the inclusion of non-English speakers will introduce another confound in this small sample size and preclude grouped analysis

• 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.

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Texas
The University of Texas Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Nitin Tandon, MD
Nitin.Tandon@uth.tmc.edu
713-500-5443
Backup
Eliana M Klier, PhD
Eliana.Klier@uth.tmc.edu
713-500-5442
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 8
Treatments
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
Sponsors
Leads: Nitin Tandon
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov