Lennox Gastaut SyndromePESLNCT06464653
Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome
A study testing Forel's Field H-DBS ON in people with Lennox Gastaut Syndrome, run by Liankun_Ren at 1 site in China.
Trial summary
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of pallidothalamic tracts as adjunctive therapy for alleviating symptoms in Lennox-Gastaut Syndrome. Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- Lennox Gastaut Syndrome
- What is being tested?
- Forel's Field H-DBS ON
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Dec 2026
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meets the diagnostic criteria for Lennox-Gastaut Syndrome (LGS) based on comprehensive assessment of medical history, seizure semiology, and electroencephalographic (EEG) findings during both ictal and interictal periods;
- Interictal EEG demonstrates generalized paroxysmal fast activity (GPFA) and slow spike-and-wave (SSW) complexes;
- Generalized tonic-clonic seizures (GTCs) have been captured in prior video-EEG monitoring, or seizure episodes have been clearly described by reliable eyewitnesses;
- During the screening or baseline period, the following conditions are met:
- The patient or caregiver is capable of reliably maintaining a seizure diary;
- The seizure diary indicates an average of at least 5 seizures per month;
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- The patient is on two or more antiepileptic drugs (AEDs), with a stable treatment regimen (no new add-on or withdrawal of AEDs, excluding temporary rescue medications such as benzodiazepines; dose adjustments are allowed);
- The patient has been evaluated through a comprehensive presurgical epilepsy workup and is considered unsuitable for, or has declined, resective epilepsy surgery, or has had unsatisfactory outcomes from resective or ablative procedures;
- Providation of written informed consent, demonstrates adequate compliance with the study protocol, and agrees to participate in this clinical study.
Who cannot join
- Unable to provide a reliable seizure diary by self or legal guardian;
- Predominant seizure type is focal impaired awareness seizures;
- Psychogenic non-epileptic seizures within 12 months;
- Brain structual abnormalities precluding safe implantation of deep brain stimulator;
- Conditions associated with increased risk of intraoperative or postoperative bleeding (e.g., coagulopathy), or requirement for long-term oral anticoagulant or antiplatelet therapy;
- Presence of other severe somatic or internal medical conditions, including significant hepatic or renal dysfunction;
- Pregnant, or planning to pregnant within 2 years.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: The Efficacy and Safety of Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome: A Prospective, Pilot Trial
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of pallidothalamic tracts as adjunctive therapy for alleviating symptoms in Lennox-Gastaut Syndrome.
Read the detailed description
This project aims to include 5 participants, and evaluate the effectiveness and safety of pallidothalamic tracts stimulation in patients with Lennox-Gastaut Syndrome through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with Lennox-Gastaut Syndrome with alternative treatment options.
- Conditions
- Lennox Gastaut Syndrome
- Being tested
- Forel's Field H-DBS ON
- Keywords
- Deep Brain Stimulation, Lennox-Gastaut Syndrome, Pallidothalamic Tracts
- Medical subject headings
- Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forel's Field H-DBS ONDevice
The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy. The targets used in this study is Forel's Field H. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.
| Study group | Role | What they receive |
|---|---|---|
| Pallidothalamic Tracts-DBS group | Experimental | participants will undergo Pallidothalamic Tracts-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. Receives: Device: Forel's Field H-DBS ON |
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 Forel's Field H-DBS
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 Forel's Field H-DBS
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured: Up to 1 year after Forel's Field H-DBS
Cognitive function evaluation (MMSE)
Percentage change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE score ranges from 0 to 30, with higher scores representing better cognitive function and lower scores indicating greater cognitive impairment.
Measured: Up to 1 year after Forel's Field H-DBS
Cognitive function evaluation (MoCA)
Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores suggesting greater cognitive impairment.
Measured: Up to 1 year after Forel's Field H-DBS
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Measured: Up to 1 year after Pallidothalamic Tracts-DBS
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 Forel's Field H-DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 May 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lennox Gastaut SyndromeStudies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liankun_Ren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liankun_Ren, Xuanwu Hospital, Beijing
- Investigators
- Liankun Ren, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464653
- Sponsor's protocol ID
- 2024-128-003
- Acronym
- PESL
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome: A Prospective, Pilot Trial
- ClinicalTrials.gov ID
- NCT06464653
- Acronym / sponsor ID
- PESL / 2024-128-003
- Conditions
- Lennox Gastaut Syndrome
- Keywords
- Deep Brain Stimulation, Lennox-Gastaut Syndrome, Pallidothalamic Tracts
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Liankun_RenUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Jun 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 deep brain stimulation (DBS) of pallidothalamic tracts as adjunctive therapy for alleviating symptoms in Lennox-Gastaut Syndrome.
Detailed description
This project aims to include 5 participants, and evaluate the effectiveness and safety of pallidothalamic tracts stimulation in patients with Lennox-Gastaut Syndrome through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with Lennox-Gastaut Syndrome 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 |
|---|---|---|
| Pallidothalamic Tracts-DBS group | Experimental | Device: Forel's Field H-DBS ONparticipants will undergo Pallidothalamic Tracts-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Meets the diagnostic criteria for Lennox-Gastaut Syndrome (LGS) based on comprehensive assessment of medical history, seizure semiology, and electroencephalographic (EEG) findings during both ictal and interictal periods;
- Interictal EEG demonstrates generalized paroxysmal fast activity (GPFA) and slow spike-and-wave (SSW) complexes;
- Generalized tonic-clonic seizures (GTCs) have been captured in prior video-EEG monitoring, or seizure episodes have been clearly described by reliable eyewitnesses;
- During the screening or baseline period, the following conditions are met:
- The patient has been evaluated through a comprehensive presurgical epilepsy workup and is considered unsuitable for, or has declined, resective epilepsy surgery, or has had unsatisfactory outcomes from resective or ablative procedures;
Key exclusion criteria (7 listed)
- Unable to provide a reliable seizure diary by self or legal guardian;
- Predominant seizure type is focal impaired awareness seizures;
- Psychogenic non-epileptic seizures within 12 months;
- Brain structual abnormalities precluding safe implantation of deep brain stimulator;
- Conditions associated with increased risk of intraoperative or postoperative bleeding (e.g., coagulopathy), or requirement for long-term oral anticoagulant or antiplatelet therapy;
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 |
|---|---|---|
| Forel's Field H-DBS ONThe surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy. The targets used in this study is Forel's Field H. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist. | Device | Pallidothalamic Tracts-DBS group |
Primary outcome
Seizure Frequency (SF28)
Time frame: Up to 1 year after Forel's Field H-DBS
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 Forel's Field H-DBS
Life quality evaluation
Time frame: Up to 1 year after Forel's Field H-DBS
Cognitive function evaluation (MMSE)
Time frame: Up to 1 year after Forel's Field H-DBS
Cognitive function evaluation (MoCA)
Time frame: Up to 1 year after Forel's Field H-DBS
Adverse Events
Time frame: Up to 1 year after Pallidothalamic Tracts-DBS
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
Time frame: Up to 1 year after Forel's Field H-DBS
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Liankun Ren, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forel's Field H-DBS ON in people with Lennox Gastaut Syndrome, run by Liankun_Ren 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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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?
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 Frequency (SF28) (time frame: Up to 1 year after Forel's Field H-DBS). 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 13 Apr 2026.