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Not yet recruiting NCT07082101

Temporal Interference for Temporal Lobe Epilepsy Under SEEG

No phase Interventional 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: temporal interference.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: 18 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating Biomarkers of Temporal Interference for Temporal Lobe Epilepsy Under SEEG

Overview

This study evaluates the effect of temporal interference (TI) stimulation on biomarkers in patients with temporal lobe epilepsy (TLE) under stereo-electroencephalography (SEEG), and provides theoretical basis for non-invasive TI treatment of temporal lobe epilepsy.

Detailed description

10 patients aged 18-65 years with TLE assessed by semiology, video electroencephalogram and imaging in Epilepsy Center of Xijing Hospital (Xi'an, China) will be recruited. Clinical baseline data such as general information and history of seizures will be collected. The SEEG electrodes were implanted in the Department of neurosurgery of Xijing Hospital and after 24 hours TI will be performed with continuous SEEG monitoring. Finally, the biomarker changes of EEG signals before and after TI treatment were statistically analyzed.

Interventions

  • Other temporal interference
    In this intervertion, patients with SEEG operation will take temporal interference (TI) stimulation and the deep brain EEG will be monitorated through the entire experiment.

Primary outcome measures

  • Number of interictal electrophysiological biomaker changes in epilepsy [Time frame: 24 hours after TI stimulation]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of drug refractory epilepsy and temporal lobe epilepsy;
  • Patients undergoing SEEG;
  • Able to cooperate the treatment and related inspection;
  • Fully understands and signs informed consent.

Exclusion criteria

  • Patients with temporal plus epilepsy;
  • In status epilepticus;
  • With other severe disease;
  • Pregnancy or lactation women;
  • Unable to tolerate SEEG or TI;
  • At the same time to participate in other clinical trials;
  • Withdraw consent procedure.

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

China · 1 center
  • Xijing Hospital — Xi'an

Identifiers

NCT: NCT07082101 · KY20252287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗