Brain pacemaker shows promise for rare childhood epilepsy
NCT ID NCT06464653
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether deep brain stimulation (DBS) of specific brain pathways can safely reduce seizures in people with Lennox-Gastaut syndrome, a severe form of epilepsy. Five participants receive the electrical stimulation as an add-on to their usual treatment. The goal is to see if seizure frequency drops by at least half and if quality of life improves.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2024
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
14 to 35 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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; 2. Interictal EEG demonstrates generalized paroxysmal fast activity (GPFA) and slow spike-and-wave (SSW) complexes; 3. Generalized tonic-clonic seizures (GTCs) have been captured in prior video-EEG monitoring, or seizure episodes have been clearly described by reliable eyewitnesses; 4. During the screening or baseline period, the following conditions are met: 1. The patient or caregiver is capable of reliably maintaining a seizure diary; 2. The seizure diary indicates an average of at least 5 seizures per month; 3. 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); 5. 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; 6. Providation of written informed consent, demonstrates adequate compliance with the study protocol, and agrees to participate in this clinical study. Exclusion Criteria: 1. Unable to provide a reliable seizure diary by self or legal guardian; 2. Predominant seizure type is focal impaired awareness seizures; 3. Psychogenic non-epileptic seizures within 12 months; 4. Brain structual abnormalities precluding safe implantation of deep brain stimulator; 5. Conditions associated with increased risk of intraoperative or postoperative bleeding (e.g., coagulopathy), or requirement for long-term oral anticoagulant or antiplatelet therapy; 6. Presence of other severe somatic or internal medical conditions, including significant hepatic or renal dysfunction; 7. Pregnant, or planning to pregnant within 2 years.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lennox Gastaut syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug curb seizures in children with severe epilepsy?
- Which treatment tames LGS seizures better: surgery or more meds?
- Can a slow start with CBD oil tame Hard-to-Control seizures?
- Lifeline for kids with severe epilepsy: drug access extended
- Brain implant shows promise for Hard-to-Treat seizures in rare epilepsy
- New drug shows promise for rare, severe childhood epilepsy