Mesial Temporal Lobe EpilepsyNCT05608408
PRIME: PReservIng Memory in Epilepsy
A study testing Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system in people with Mesial Temporal Lobe Epilepsy, run by Nitin Tandon at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mesial Temporal Lobe Epilepsy
- What is being tested?
- Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Nov 2023to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Texas Science Center at Houston
Houston, Texas, 77030
Jessica Johnson, MSN, NP-C, 713-500-5443, Jessica.A.Johnson@uth.tmc.edu
Eliana Klier, PhD, 713-500-5442, Eliana.Klier@uth.tmc.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Gregory Worrell, MD, PhD, worrell.gregory@mayo.edu
About this study
Official title: Network Neuro-modulation for Mesial Temporal Lobe 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) 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.
Read the detailed description
Different stimulation types will be administered in a crossover fashion, as follows. There will be four four-month periods of low-frequency DBS stimulation, and in each of these four-month periods, stimulation will occur at one of four different sites [the anterior nucleus of the thalamus (ANT), entorhinal cortex (ERC), piriform cortex (PiC), and hippocampal fornix (HCF)], with the order of receipt differing among study participants. There will be a 3-month washout period after each 4-month stimulation period, with the washout being standard of care (SOC) high-frequency DBS stimulation of the ANT. Finally, there will be a 7 to 12 month DBS stimulation period with the stimulation type that yielded the best results.
- Conditions
- Mesial Temporal Lobe Epilepsy
- Being tested
- Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system, Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC systemDevice
Stimulation of site with the Medtronic Percept PC system using low frequency stimulation at 0.5 Hz.
Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC systemDevice
Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system using standard of care high frequency stimulation parameters.
| Study group | Role | What they receive |
|---|---|---|
| Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 1 | Experimental | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seizures as self-reported by participants
Measured: baseline
Number of seizures as self-reported by participants
Measured: 2 weeks
Number of seizures as self-reported by participants
Measured: 4 weeks
Number of seizures as self-reported by participants
Measured: 6 weeks
Number of seizures as self-reported by participants
Measured: 8 weeks
Number of seizures as self-reported by participants
Measured: 10 weeks
Number of seizures as self-reported by participants
Measured: 12 weeks
Number of seizures as self-reported by participants
Measured: 14 weeks
Number of seizures as self-reported by participants
Measured: 16 weeks
Number of seizures as assessed by EEG
Measured: baseline
Number of seizures as assessed by EEG
Measured: 4 months
Number of seizures as assessed by the Percept PC
Measured: baseline
Number of seizures as assessed by the Percept PC
Measured: 4 months
Number of inter-ictal spikes as assessed by the Percept PC
Measured: baseline
Number of inter-ictal spikes as assessed by the Percept PC
Measured: 4 months
Secondary outcomes (8)
Verbal memory as assessed by score on the California Verbal Learning Test second edition
Individuals read a list of 16 words and are asked to repeat them immediately for each of 5 trials.
Measured: baseline
Verbal memory as assessed by score on the California Verbal Learning Test second edition
Individuals read a list of 16 words and are asked to repeat them immediately for each of 5 trials.
Measured: 4 months
Verbal memory as assessed by score on the Logical Memory I and II subtests from the Wechsler Memory Scale - IV
Measured: baseline
Verbal memory as assessed by score on the Logical Memory I and II subtests from the Wechsler Memory Scale - IV
Measured: 4 months
Wellness as assessed by score on the the Quality of Life in Epilepsy 31 (QOLIE-31) survey
QOLIE-31 total score ranges from 0 to 100, with a higher score indicating a more favorable quality of life.
Measured: baseline
Wellness as assessed by score on the Quality of Life in Epilepsy 31 (QOLIE-31) survey
QOLIE-31 total score ranges from 0 to 100, with a higher score indicating a more favorable quality of life.
Measured: 4 months
Wellness as assessed by score on the 36-Item Short Form Health Survey (SF-36)
SF-36 total score ranges from 0 to 100, with a higher score indicating a better health status.
Measured: baseline
Wellness as assessed by score on the 36-Item Short Form Health Survey (SF-36)
SF-36 total score ranges from 0 to 100, with a higher score indicating a better health status.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start16 Nov 2023
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesial Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitin Tandon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Nitin Tandon, The University of Texas Health Science Center, Houston
- Investigators
- Nitin Tandon, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608408
- Sponsor's protocol ID
- HSC-MS-22-0136
- Other IDs
- 1UH3NS119834
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Neuro-modulation for Mesial Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT05608408
- Acronym / sponsor ID
- HSC-MS-22-0136
- Conditions
- Mesial Temporal Lobe Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Nitin TandonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Different stimulation types will be administered in a crossover fashion, as follows. There will be four four-month periods of low-frequency DBS stimulation, and in each of these four-month periods, stimulation will occur at one of four different sites [the anterior nucleus of the thalamus (ANT), entorhinal cortex (ERC), piriform cortex (PiC), and hippocampal fornix (HCF)], with the order of receipt differing among study participants. There will be a 3-month washout period after each 4-month stimulation period, with the washout being standard of care (SOC) high-frequency DBS stimulation of the ANT. Finally, there will be a 7 to 12 month DBS stimulation period with the stimulation type that yielded the best results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC systemStimulation of site with the Medtronic Percept PC system using low frequency stimulation at 0.5 Hz. | Device | 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 |
| Standard of Care (SOC) High Frequency Stimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC systemStimulation of the Anterior Nucleus of the Thalamus (ANT) with the Medtronic Percept PC system using standard of care high frequency stimulation parameters. | Device | 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 |
Primary outcome
Number of seizures as self-reported by participants
Time frame: baseline
Number of seizures as self-reported by participants
Time frame: 2 weeks
Number of seizures as self-reported by participants
Time frame: 4 weeks
Number of seizures as self-reported by participants
Time frame: 6 weeks
Number of seizures as self-reported by participants
Time frame: 8 weeks
Number of seizures as self-reported by participants
Time frame: 10 weeks
Number of seizures as self-reported by participants
Time frame: 12 weeks
Number of seizures as self-reported by participants
Time frame: 14 weeks
Number of seizures as self-reported by participants
Time frame: 16 weeks
Number of seizures as assessed by EEG
Time frame: baseline
Number of seizures as assessed by EEG
Time frame: 4 months
Number of seizures as assessed by the Percept PC
Time frame: baseline
Number of seizures as assessed by the Percept PC
Time frame: 4 months
Number of inter-ictal spikes as assessed by the Percept PC
Time frame: baseline
Number of inter-ictal spikes as assessed by the Percept PC
Time frame: 4 months
8 secondary outcomes
Verbal memory as assessed by score on the California Verbal Learning Test second edition
Time frame: baseline
Verbal memory as assessed by score on the California Verbal Learning Test second edition
Time frame: 4 months
Verbal memory as assessed by score on the Logical Memory I and II subtests from the Wechsler Memory Scale - IV
Time frame: baseline
Verbal memory as assessed by score on the Logical Memory I and II subtests from the Wechsler Memory Scale - IV
Time frame: 4 months
Wellness as assessed by score on the the Quality of Life in Epilepsy 31 (QOLIE-31) survey
Time frame: baseline
Wellness as assessed by score on the Quality of Life in Epilepsy 31 (QOLIE-31) survey
Time frame: 4 months
Wellness as assessed by score on the 36-Item Short Form Health Survey (SF-36)
Time frame: baseline
Wellness as assessed by score on the 36-Item Short Form Health Survey (SF-36)
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitin Tandon, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Frequency Stimulation (LFS) of site with the Medtronic Percept PC system in people with Mesial Temporal Lobe Epilepsy, run by Nitin Tandon at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitin Tandon, MD (713-500-5443, Nitin.Tandon@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of seizures as self-reported by participants (time frame: baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.