Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy

NCT06341075 | Enrolling By Invitation DMC

• 1 other identifier: KY2024-053-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the real-world study is to evaluate the long-term seizure control outcomes, postoperative complications, long term impact on cognitive, memory function outcomes, quality-of-life measures, and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) on patients with drug-resistant epilepsy (DRE).

Conditions

Drug Resistant Epilepsy

Keywords

MRgLITT; Drug-resistant Epilepsy; Seizure Control; Functional Preservation; Real-world STUDY

Outcome Measures

Primary Outcomes (1)

• Seizure-freedom rate

  Percentage

  6-month, 1-year and 2-year after surgery

Secondary Outcomes (10)

• Seizure frequency reduction

  6-month, 1-year and 2-year after surgery

• ILAE classification of outcome

  6-month, 1-year and 2-year after surgery

• Seizure severity

  6-month, 1-year and 2-year after surgery

• Rate of mild complications

  Within 1 month after surgery

• Cognitive function evaluation

  6-month, 1-year and 2-year after surgery

Study Arms (2)

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

EXPERIMENTAL

Novel, minimally invasive MRgLITT.

Device: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

Open Surgery (OS)

NO INTERVENTION

Traditional OS, including ATL, SAH and so on.

Interventions

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) DEVICE

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

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 12 and 75 (provided that rigorous prior studies have been done to suggest appropriate dosing for ages 12 and above);
• Patients or the assents are able to provide informed consent;
• Ability to keep accurate seizure diaries;
• Complete presurgical evaluation information;
• Meets the 2009 ILAE definition of DRE (Failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapy or in combination) to achieve sustained seizure freedom) ;

You may not qualify if:

• Subjects with significant progressive disorders or unstable medical conditions requiring acute intervention;
• Clinically relevant abnormalities in bloodwork detected (e.g., rising or new onset 3X liver function tests \[LFTs\]);
• Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt;
• A psychiatric disorder where changes in pharmacotherapy are needed or anticipated during the study;
• Diagnosed with intracranial space-occupying lesions or dual pathology by neuroimaging inspection;
• Women who are pregnant, planning to become pregnant during the study period, or currently breastfeeding may be excluded due to the potential risks associated with surgery and anesthesia;
• Patients with a history of previous brain surgery, including prior epilepsy surgery, that may interfere with the study objectives or confound the interpretation of results may be excluded;
• Any condition that may impact a patient's ability to follow study procedures or patient's safety, based on what is known about the pharmacology/toxicology profile of the trial agent(s);

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

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: 37800596 RESULT

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kai Zhang, Dr.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 2, 2024
• Study Start: March 14, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

CN (1)