NCT06720922

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jul 2025Jan 2028

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

July 21, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 21, 2026

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

December 3, 2024

Last Update Submit

January 19, 2026

Conditions

Keywords

Magnetic Resonance-guided Laser Interstitial Thermal TherapyOpen SurgeryTemporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Seizure freedom rate

    According to International League Against Epilepsy \[ILAE\] Outcome Scale

    6-month, 1-year after surgery

Secondary Outcomes (10)

  • Seizure frequency

    6-month, 1-year after surgery

  • Seizure severity

    6-month, 1-year after surgery

  • Cognitive function evaluation

    6-month, 1-year after surgery

  • Memory function evaluation

    6-month, 1-year after surgery

  • Quality of life for epilepsy patients

    6-month, 1-year after surgery

  • +5 more secondary outcomes

Study Arms (2)

Open Surgery (anterior temporal lobectomy, ATL)

EXPERIMENTAL
Procedure: Open Surgery

Minimally Invasive Surgery (MRgLITT)

ACTIVE COMPARATOR
Procedure: Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

Interventions

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

Minimally Invasive Surgery (MRgLITT)
Open SurgeryPROCEDURE

Traditional Open Surgery

Open Surgery (anterior temporal lobectomy, ATL)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37800596BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Epilepsies, PartialEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

July 21, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 21, 2026

Record last verified: 2025-07

Locations