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Not yet recruiting NCT07128563

Piriform Cortex Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis

No phase Interventional Epilepsy, Drug Resistant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: piriform cortex-DBS.
Who it may be relevant to
Registry conditions: Epilepsy, Drug Resistant. Basic parameters: 14 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Piriform cortex as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis

Detailed description

This project aims to include 5 participants, and evaluate the effectiveness and safety of piriform cortex stimulation in patients with temporal lobe epilepsy and bilateral hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with temporal lobe epilepsy and bilateral hippocampal sclerosis with alternative treatment options.

Interventions

  • Device piriform cortex-DBS
    The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are biliteral piriform cortex.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.

Primary outcome measures

  • Seizure frequency (SF28) [Time frame: Up to 1 year after piriform cortex-DBS]
Secondary outcome measures (6)
  • Seizure Responder Rate [Time frame: Up to 1 year after piriform cortex-DBS]
  • Life quality evaluation [Time frame: Up to 1 year after piriform cortex-DBS]
  • Cognitive function evaluation (MMSE) [Time frame: Up to 1 year after piriform cortex-DBS]
  • Cognitive function evaluation (MoCA) [Time frame: Up to 1 year after piriform cortex-DBS]
  • Adverse Events [Time frame: Up to 1 year after piriform cortex-DBS]
  • Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) [Time frame: Up to 1 year after piriform cortex-DBS]

Eligibility criteria

Inclusion criteria

  • Participants are between the ages of 14 -65 years of age
  • Refractory to anti-seizure medications (ASMs).
  • Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month.
  • After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
  • Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy
  • Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
  • Informed consent signed.

Exclusion criteria

  • Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
  • Psychogenic non-epileptic seizures within 12 months;
  • Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
  • Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
  • IQ < 55 or severe cognitive dysfunction, unable to complete the study;
  • Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
  • Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
  • Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
  • Pregnant, or planning to pregnant within 2 years;
  • Participation in another clinical study within 3 months;
  • Not suitable for enrollment as assessed by the multidisciplinary team of the center.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07128563 · 2025-212-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗