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Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy

NCT05019404 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-12-30

No results posted yet for this study

Summary

Temporal lobe epilepsy (TLE) is a chronically neurological disease characterized by progressive seizures. TLE is the most frequent subtype of refractory focal epilepsy in adults. Epilepsy surgery has proven to be very efficient in TLE and superior to medical therapy in two randomized controlled trials. According to the previous experience, the investigators use functional anterior temporal lobectomy (FATL) via minicraniotomy for TLE. To date, this minimally invasive open surgery has been not reported. The investigators here present a protocol of a prospective trail which for the first time evaluates the outcomes of this new surgical therapy for TLE.

Conditions

  • Temporal Lobe Epilepsy
  • Open Surgery
  • Minimally Invasive Surgery

Interventions

PROCEDURE

Functional anterior temporal lobectomy (FATL)

Patients are placed in the supine position with the head contralaterally rotated 30°. The 3D model of incision and bone flap is printed prior to surgery by the slicer software based on the MRI data. Slightly curve incision with the length of about 6 cm in the temporal region is marked according to the 3D model. Temporal craniotomy via small bone window with the diameter of about 3 cm is performed. From the temporal pole along T1 about 5 cm posteriorly, temporal horn is opened by dissecting the middle temporal gyrus. The head of temporal horn is exposed. The amygdala is resected. Then, the parahippocampal gyrus and hippocampus are en bloc resected. The lateral temporal lobotomy is easy due to large view following the removal of mesial structures. The lateral posterior temporal lobotomy is no more than 5 cm from the temporal pole.

PROCEDURE

Anterior temporal lobectomy (ATL)

Patients are placed in the supine position with the head contralaterally rotated 30°. Large frontotemporal craniotomy is performed. Question mark-shaped incision with the length of 20- 25 cm in the frontotemporal region is marked. The size of the bone flap is approximately 5×7 cm for the exposure of lateral temporal lobe. ATL consists of en bloc resection of the anterior 5 cm of lateral temporal lobe, followed by the removal of mesial structures including the amygdala, parahippocampal gyrus, and hippocampus.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Hua Zhang, PhD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2024-09-01
Completion
2025-09-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05019404 on ClinicalTrials.gov