Mesial Temporal Lobe Epilepsy With Hippocampal SclerosisNCT06558864
High Selective Subiculum SEEG Guided RF-TC for mTLE-HS
A study testing Subiculum RF-TC in people with Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis and Epilepsy, run by Xuanwu Hospital, Beijing.
Trial summary
The primary objective of this research is to study the efficacy and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with Mesial temporal lobe epilepsy with hippocampal… Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis, Epilepsy
- What is being tested?
- Subiculum RF-TC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 9 Aug 2024to 20 Aug 2027
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants are between the ages of 14 -65 years of age
- Refractory to anti-seizure medications (ASMs).
- Persistence of disabling seizures at least 2 times per month during the Baseline Phase，with no more than 30 days between seizures during the Baseline Phase.
- Hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
- Interictal EEG shows focal or lateralized spikes on temporal, frontal zone, or sphenoid electrode
- Ictal EEG onset is focal or lateralized on the ipsilateral side
- Ipsilateral temporal focal hypometabolism on PET
- Must be agreed by a consensus of ipsilateral mesial temporal origin by a multidisciplinary discussion
Who cannot join
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
- Psychogenic non-epileptic seizures within 12 months;
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
- IQ < 55 or severe cognitive dysfunction, unable to complete the study;
- Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
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- Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
- Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
- Pregnant, or planning to pregnant within 2 years;
- Participation in another clinical study within 3 months;
- Not suitable for enrollment as assessed by the multidisciplinary team of the center.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy and Safety of Subiculum Stereotactic-EEG Guided Radio-frequency Thermocoagulation for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis: A Prospective, Single-Arm Trial
The primary objective of this research is to study the efficacy and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with Mesial temporal lobe epilepsy with hippocampal sclerosis (mTLE-HS).
Read the detailed description
Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. This project aims to include 20 participants, and evaluate the effectiveness and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum in patients with mesial temporal lobe epilepsy with hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with mTLE-HS with alternative treatment options.
- Being tested
- Subiculum RF-TC
- Keywords
- Radio-frequency thermocoagulation, Stereoelectroencephalography, Subiculum
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subiculum RF-TCProcedure or surgery
SEEG implantation after evaluation, record the interictal and ictal EEG, and perform Subiculum RF-TC.
| Study group | Role | What they receive |
|---|---|---|
| Subiculum RF-TC group | Experimental | SEEG recording and Subiculum RF-TC minimal invasive treatment for mTLE-HS Receives: Procedure: Subiculum RF-TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency (SF28)
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval:
SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100*(double-blind SF28-baseline SF28)/baseline SF28.
Measured: Up to 1 year after subculum-SEEG Guided RF-TC
Secondary outcomes (6)
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Measured: Up to 1 year after subculum-SEEG Guided RF-TC
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.
Measured: Up to 1 year after subculum-SEEG Guided RF-TC
Cognitive function evaluation (MMSE)
Percentage change from baseline in Mini-Mental State Examination (MMSE) score.
Measured: Up to 1 year after subculum-SEEG Guided RF-TC
Cognitive function evaluation (MoCA)
Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score.
Measured: Up to 1 year after subculum-SEEG Guided RF-TC
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Measured: Up to 1 year after subculum-SEEG Guided RF-TC
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.
Measured: Up to 1 year after subculum-SEEG Guided RF-TC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start9 Aug 2024 (estimated)
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesial Temporal Lobe Epilepsy With Hippocampal SclerosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liankun Ren, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558864
- Sponsor's protocol ID
- 2024-174-002
- Status last verified
- Jul 2024
- First submitted
- 4 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Subiculum Stereotactic-EEG Guided Radio-frequency Thermocoagulation for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis: A Prospective, Single-Arm Trial
- ClinicalTrials.gov ID
- NCT06558864
- Acronym / sponsor ID
- 2024-174-002
- Keywords
- Radio-frequency thermocoagulation, Stereoelectroencephalography, Subiculum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 9 Aug 2024 (estimated)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 19 Aug 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.
The primary objective of this research is to study the efficacy and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with Mesial temporal lobe epilepsy with hippocampal sclerosis (mTLE-HS).
Detailed description
Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. This project aims to include 20 participants, and evaluate the effectiveness and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum in patients with mesial temporal lobe epilepsy with hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with mTLE-HS with alternative treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subiculum RF-TC group | Experimental | Procedure: Subiculum RF-TCSEEG recording and Subiculum RF-TC minimal invasive treatment for mTLE-HS |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Participants are between the ages of 14 -65 years of age
- Refractory to anti-seizure medications (ASMs).
- Persistence of disabling seizures at least 2 times per month during the Baseline Phase，with no more than 30 days between seizures during the Baseline Phase.
- Hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
- Interictal EEG shows focal or lateralized spikes on temporal, frontal zone, or sphenoid electrode
Key exclusion criteria (11 listed)
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
- Psychogenic non-epileptic seizures within 12 months;
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
- IQ < 55 or severe cognitive dysfunction, unable to complete the study;
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 |
|---|---|---|
| Subiculum RF-TCSEEG implantation after evaluation, record the interictal and ictal EEG, and perform Subiculum RF-TC. | Procedure or surgery | Subiculum RF-TC group |
Primary outcome
Seizure frequency (SF28)
Time frame: Up to 1 year after subculum-SEEG Guided RF-TC
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100*(double-blind SF28-baseline SF28)/baseline SF28.
6 secondary outcomes
Seizure Responder Rate
Time frame: Up to 1 year after subculum-SEEG Guided RF-TC
Life quality evaluation
Time frame: Up to 1 year after subculum-SEEG Guided RF-TC
Cognitive function evaluation (MMSE)
Time frame: Up to 1 year after subculum-SEEG Guided RF-TC
Cognitive function evaluation (MoCA)
Time frame: Up to 1 year after subculum-SEEG Guided RF-TC
Adverse Events
Time frame: Up to 1 year after subculum-SEEG Guided RF-TC
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
Time frame: Up to 1 year after subculum-SEEG Guided RF-TC
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 19 Aug 2024.
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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.
Liankun Ren, MD principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing Subiculum RF-TC in people with Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis and Epilepsy, run by Xuanwu Hospital, Beijing.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Liankun Ren (+86 13681576621, renlk2022@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (SF28) (time frame: Up to 1 year after subculum-SEEG Guided RF-TC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2024.