MRgLITT for mTLE: A PROBE Trial

NCT ID: NCT06720922

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-21

Study Completion Date

2028-01-01

Brief Summary

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How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in mesial temporal lobe epilepsy (mTLE)?

Detailed Description

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1. Compare the clinical prognosis between magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) and traditional open surgery (OS) on patients with mesial temporal lobe epilepsy (mTLE).
2. Explore the factors associated with seizure outcomes.

Conditions

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Temporal Lobe Epilepsy (TLE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Open Surgery (anterior temporal lobectomy, ATL)

Group Type EXPERIMENTAL

Open Surgery

Intervention Type PROCEDURE

Traditional Open Surgery

Minimally Invasive Surgery (MRgLITT)

Group Type ACTIVE_COMPARATOR

Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

Intervention Type PROCEDURE

MRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue.

Interventions

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Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

MRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue.

Intervention Type PROCEDURE

Open Surgery

Traditional Open Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-65 years.
* Drug-resistant mesial temporal lobe epilepsy.
* Seizure frequency ≥ 1 time /month.
* Participants approved.

Exclusion Criteria

* History of brain surgery.
* Intracranial space occupying lesions.
* Individuals with significant medical comorbidities or conditions that pose an excessive risk for surgery, such as severe cardiovascular disease, respiratory disorders, or uncontrolled systemic infections.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kai Zhang

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Zhang, Dr.

Role: CONTACT

86 01059975051

Facility Contacts

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Jiajie Mo, Dr.

Role: primary

86 01059975051

References

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Mo J, Guo Z, Wang X, Zhang J, Hu W, Shao X, Sang L, Zheng Z, Zhang C, Zhang K. Magnetic resonance-guided laser interstitial thermal therapy vs. open surgery for drug-resistant mesial temporal lobe epilepsy: a propensity score matched retrospective cohort study. Int J Surg. 2024 Jan 1;110(1):306-314. doi: 10.1097/JS9.0000000000000811.

Reference Type BACKGROUND
PMID: 37800596 (View on PubMed)

Other Identifiers

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KY2025-073-02

Identifier Type: -

Identifier Source: org_study_id

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