Temporal Lobe Epilepsy (TLE)MINENCT06720922
MRgLITT for mTLE: A PROBE Trial
A study testing Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) and Open Surgery in people with Temporal Lobe Epilepsy (TLE), run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in mesial temporal lobe epilepsy (mTLE)? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporal Lobe Epilepsy (TLE)
- What is being tested?
- Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) and Open Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18-65 years.
- Drug-resistant mesial temporal lobe epilepsy.
- Seizure frequency ≥ 1 time /month.
- Participants approved.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Jiajie Mo, Dr., 86 01059975051, jiajiemo@foxmail.com
About this study
Official title: Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Mesial Temporal Lobe Epilepsy: A Prospective, Randomized, Open Blinded, End-point Trial
How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in mesial temporal lobe epilepsy (mTLE)?
Read the detailed description
- 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).
- Explore the factors associated with seizure outcomes.
- Conditions
- Temporal Lobe Epilepsy (TLE)
- Being tested
- Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT), Open Surgery
- Keywords
- Magnetic Resonance-guided Laser Interstitial Thermal Therapy, Open Surgery, Temporal Lobe Epilepsy
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)Procedure or surgery
MRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue.
Open SurgeryProcedure or surgery
Traditional Open Surgery
| Study group | Role | What they receive |
|---|---|---|
| Open Surgery (anterior temporal lobectomy, ATL) | Experimental | Not described Receives: Procedure: Open Surgery |
| Minimally Invasive Surgery (MRgLITT) | Active comparator | Not described Receives: Procedure: Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure freedom rate
According to International League Against Epilepsy [ILAE] Outcome Scale
Measured: 6-month, 1-year after surgery
Secondary outcomes (10)
Seizure frequency
Times/Months
Measured: 6-month, 1-year after surgery
Seizure severity
National Hospital Seizure Severity Scale (NHS3)
Measured: 6-month, 1-year after surgery
Cognitive function evaluation
Multiple Ability Self-Report Questionnaire (MASQ)
Measured: 6-month, 1-year after surgery
Memory function evaluation
Multifactorial Memory Questionnaire (MMQ)
Measured: 6-month, 1-year after surgery
Quality of life for epilepsy patients
EQ-5D-5L
Measured: 6-month, 1-year after surgery
Adverse events
percentage
Measured: within 7 days, 6-month, 1-year after surgery
Severe adverse events
percentage
Measured: within 7 days, 6-month, 1-year after surgery
Length of hospital stay
days
Measured: after surgery
Rate of antiepileptic drug reduction or withdrawn
percentage
Measured: 1-year after surgery
Rate of reoperations
percentage
Measured: 1-year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start21 Jul 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporal Lobe Epilepsy (TLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Zhang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720922
- Sponsor's protocol ID
- KY2025-073-02
- Acronym
- MINE
- Status last verified
- Jul 2025
- First submitted
- 3 Dec 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 37800596Mo J, Cai D, Zhou Q, Dong S, Li Q, Zhao B, Wang X, Zhang C, Hu W, Zheng Z, Sang L, Shao X, Zhang J, Zhu L, Wang Z, Wu Y, Wang A, Zhang K. Magnetic resonance-guided laser interstitial thermal therapy for mesial temporal lobe epilepsy (MINE): a single-centre, prospective, randomised, open-label, blinded-endpoint controlled trial protocol in China. BMJ Open. 2026 Jul 9;16(7):e117930. doi: 10.1136/bmjopen-2026-117930.
PubMed 42425569
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Mesial Temporal Lobe Epilepsy: A Prospective, Randomized, Open Blinded, End-point Trial
- ClinicalTrials.gov ID
- NCT06720922
- Acronym / sponsor ID
- MINE / KY2025-073-02
- Conditions
- Temporal Lobe Epilepsy (TLE)
- Keywords
- Magnetic Resonance-guided Laser Interstitial Thermal Therapy, Open Surgery, Temporal Lobe Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in mesial temporal lobe epilepsy (mTLE)?
Detailed description
- 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).
- Explore the factors associated with seizure outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Surgery (anterior temporal lobectomy, ATL) | Experimental | Procedure: Open Surgery |
| Minimally Invasive Surgery (MRgLITT) | Active comparator | Procedure: Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years.
- Drug-resistant mesial temporal lobe epilepsy.
- Seizure frequency ≥ 1 time /month.
- Participants approved.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)MRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue. | Procedure or surgery | Minimally Invasive Surgery (MRgLITT) |
| Open SurgeryTraditional Open Surgery | Procedure or surgery | Open Surgery (anterior temporal lobectomy, ATL) |
Primary outcome
Seizure freedom rate
Time frame: 6-month, 1-year after surgery
According to International League Against Epilepsy [ILAE] Outcome Scale
10 secondary outcomes
Seizure frequency
Time frame: 6-month, 1-year after surgery
Seizure severity
Time frame: 6-month, 1-year after surgery
Cognitive function evaluation
Time frame: 6-month, 1-year after surgery
Memory function evaluation
Time frame: 6-month, 1-year after surgery
Quality of life for epilepsy patients
Time frame: 6-month, 1-year after surgery
Adverse events
Time frame: within 7 days, 6-month, 1-year after surgery
Severe adverse events
Time frame: within 7 days, 6-month, 1-year after surgery
Length of hospital stay
Time frame: after surgery
Rate of antiepileptic drug reduction or withdrawn
Time frame: 1-year after surgery
Rate of reoperations
Time frame: 1-year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 37800596Mo 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.
- Derived from this study: PubMed 42425569Mo J, Cai D, Zhou Q, Dong S, Li Q, Zhao B, Wang X, Zhang C, Hu W, Zheng Z, Sang L, Shao X, Zhang J, Zhu L, Wang Z, Wu Y, Wang A, Zhang K. Magnetic resonance-guided laser interstitial thermal therapy for mesial temporal lobe epilepsy (MINE): a single-centre, prospective, randomised, open-label, blinded-endpoint controlled trial protocol in China. BMJ Open. 2026 Jul 9;16(7):e117930. doi: 10.1136/bmjopen-2026-117930.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) and Open Surgery in people with Temporal Lobe Epilepsy (TLE), 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Zhang, Dr. (86 01059975051, zhangkai62035@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure freedom rate (time frame: 6-month, 1-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 NCT06720922, which also lists 2 linked publications.
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 21 Jan 2026.