Using Deep Brain Stimulation to Preserve Memory in Epilepsy
Official title: Network Neuro-modulation for Mesial Temporal Lobe Epilepsy
Run by The University of Texas Health Science Center, Houston · NCT05608408 · Data updated 2026-11-12
This study is testing whether a new brain stimulation technique can help people with Mesial Temporal Lobe Epilepsy have fewer seizures and better memory.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Status | Recruiting |
| Started | November 16, 2023 |
| Main results expected | March 31, 2029 |
| Study ends | March 31, 2029 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT05608408 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with a diagnosis of epilepsy arising from the hippocampus and preserved verbal memory.
✕Probably not a fit
Patients with severe cognitive impairments or those who do not meet the seizure frequency criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of unilateral Deep Brain Stimulation (DBS) on patients with Mesial Temporal Lobe Epilepsy, focusing on preserving memory function. Participants will undergo a series of low-frequency stimulation sessions at various brain sites, with a crossover design that includes washout periods of standard high-frequency stimulation. The goal is to determine if targeted low-frequency stimulation can reduce seizure frequency and severity while improving memory performance. The study utilizes advanced neurostimulation technology to tailor treatment based on individual brain network architecture.
Why it matters
Potential benefit: If successful, this approach could significantly reduce seizure frequency and improve memory function in patients with epilepsy.
How similar studies have gone: Other studies have shown promise with deep brain stimulation for epilepsy, but this specific approach focusing on memory preservation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 who are unable to speak or comprehend English. The inclusion of multiple languages will make task development and grouped comparisons of neuro-psychology data difficult. * 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).
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
The University of Texas Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Nitin Tandon, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Nitin Tandon, MD
- Email: Nitin.Tandon@uth.tmc.edu
- Phone: 713-500-5443
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gene therapy for adults with refractory mesial temporal lobe epilepsy
This study is testing a new gene therapy called AMT-260 to see if it can help adults with a type of epilepsy called mesial temporal lobe epilepsy by reducing their seizures.
-
Neural cell therapy for drug-resistant epilepsy
This study is testing a new treatment that involves injecting special nerve cells into the brains of people with hard-to-treat epilepsy to see if it can help reduce their seizures.
-
Circadian Variation of Anti-Factor Xa in Trauma Patients on LMWH
This study tests whether anti-Factor Xa levels show a daily rhythm in hospitalized trauma patients receiving LMWH for VTE prevention.
-
PrioritiesAI: A chat tool to help older adults with hernia decide what matters most for surgery
This study tests an AI-powered chat assistant to help people with hernia clearly express and communicate their health goals for elective surgery.
-
Family-based program to reduce risk factors for schizophrenia spectrum disorders in youth with family history
This study tests a brief family-based psychosocial program to see if it lowers persistent psychotic-like experiences in kids and young adults with a family history of SSD and different brain risk patterns.
-
EUS-Guided RFA for Pancreatic Lesions: Safety and Outcomes
This study tests whether using endoscopic ultrasound-guided radiofrequency ablation is safe and helps patients with pancreatic lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.