Temporal Interference for Temporal Lobe Epilepsy Under SEEG (TITE-SEEG)

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Epilepsy

Treatments: Other: temporal interference

Study type: Interventional

Funder types: Other

Identifiers

NCT07082101

KY20252287

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Temporal interference

Experimental group

Treatment:

Other: temporal interference