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Not yet recruiting NCT06558864

High Selective Subiculum SEEG Guided RF-TC for mTLE-HS

No phase Interventional Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis Epilepsy

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: Subiculum RF-TC.
Who it may be relevant to
Registry conditions: Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis, Epilepsy. 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 →

Official title

The Efficacy and Safety of Subiculum Stereotactic-EEG Guided Radio-frequency Thermocoagulation for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis: A Prospective, Single-Arm Trial

Overview

The primary objective of this research is to study the efficacy and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with Mesial temporal lobe epilepsy with hippocampal sclerosis (mTLE-HS).

Detailed description

Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. This project aims to include 20 participants, and evaluate the effectiveness and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum in patients with mesial temporal lobe epilepsy with hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with mTLE-HS with alternative treatment options.

Interventions

  • Procedure Subiculum RF-TC
    SEEG implantation after evaluation, record the interictal and ictal EEG, and perform Subiculum RF-TC.

Primary outcome measures

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

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 2 times per month during the Baseline Phase，with no more than 30 days between seizures during the Baseline Phase.
  • Hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
  • Interictal EEG shows focal or lateralized spikes on temporal, frontal zone, or sphenoid electrode
  • Ictal EEG onset is focal or lateralized on the ipsilateral side
  • Ipsilateral temporal focal hypometabolism on PET
  • Must be agreed by a consensus of ipsilateral mesial temporal origin by a multidisciplinary discussion

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: NCT06558864 · 2024-174-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗