AzTrials
AzTrials

Drug Resistant EpilepsyNCT06341075

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

A study testing Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) in people with Drug Resistant Epilepsy, run by Beijing Tiantan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Drug Resistant Epilepsy
What is being tested?
Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
14 Mar 2024to 14 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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) ;

Who cannot join

  • 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);

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Patients With Drug-resistant Epilepsy

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).

Read the detailed description

Epilepsy, a complex neurological disorder characterized by recurrent seizures, affects millions of individuals worldwide, challenging both patients and healthcare providers. The main indication for the epilepsy surgery is the drug resistance as per the consensus from the Task Force of the International League Against Epilepsy (ILAE). Traditional open surgery is an established treatment for drug-resistant epilepsy (DRE), but has limitations such as invasiveness and long recovery times. With the significant advancements of technology, the minimally invasive therapeutic approaches have emerged, among which Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) stands out as a promising intervention. It provides targeted ablation of epileptogenic tissue while preserving healthy brain regions. Understanding MRgLITT's comprehensive value for DRE is of increasing interest.

This real-world study aims to comprehensively evaluate the clinical outcomes, safety profiles, and cost-effectiveness of MRgLITT in patients with DRE. The results of this clinical trial protocol are expected to serve as a comprehensive guide for researchers, clinicians, and stakeholders interested in the treatment of DRE using MRgLITT. We believe this study can influence future treatment strategies, leading to improved outcomes and enhanced quality of life for individuals with epilepsy.

Being tested
Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)
Keywords
MRgLITT, Drug-resistant Epilepsy, Seizure Control, Functional Preservation, Real-world STUDY
Medical subject headings
Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06341075
Study groupRoleWhat they receive
Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)ExperimentalNovel, minimally invasive MRgLITT.
Receives: Device: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)
Open Surgery (OS)No interventionTraditional OS, including ATL, SAH and so on.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seizure-freedom rate

    Percentage

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

Secondary outcomes (10)

  1. Seizure frequency reduction

    Times/Months

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

  2. ILAE classification of outcome

    International League Against Epilepsy (ILAE) Outcome Scale. The scale ranges from 1 to 6. The higher value indicates more frequency seizures.

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

  3. Seizure severity

    National Hospital Seizure Severity Scale (NHS3). The scale generates a score from 1 to 27. Higher score indicates more severer seizures.

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

  4. Rate of mild complications

    Percentage

    Measured: Within 1 month after surgery

  5. Cognitive function evaluation

    Multiple Ability Self-Report Questionnaire (MASQ). The questionnaire ranges from 38 to 190. Higher score indicates more severer cognitive dysfunction.

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

  6. Memory function evaluation

    Memory Functioning Scale Self-Report (MFS-S). The questionnaire ranges from 0 to 42. Higher score indicates more severer memory dysfunction.

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

  7. The quality of life

    The EuroQol 5 Dimension 5 Level (ED-5Q-5L). The questionnaire ranges from 0 to 100. Higher score indicates better quality of life.

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

  8. Length of hospital stay

    Days

    Measured: Within 1 month after surgery

  9. Rate of reoperations

    Percentage

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

  10. Rate of antiepileptic drug reduction or withdrawn

    Percentage

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start14 Mar 2024
  3. Primary completion14 Mar 2025 (estimated)
  4. Study completion14 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341075
Sponsor's protocol ID
KY2024-053-02
Status last verified
Apr 2024
First submitted
21 Mar 2024
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact jiajiemo@foxmail.com

Publications

  • 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.

    PubMed 37800596

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) in people with Drug Resistant Epilepsy, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seizure-freedom rate (time frame: 6-month, 1-year and 2-year after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06341075, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in