Electrical stimulation for treating Lennox-Gastaut Syndrome

The Efficacy and Safety of Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome: a Prospective, Pilot Trial

This study is testing whether deep brain stimulation can help young people with Lennox-Gastaut Syndrome who have ongoing severe seizures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 14 Years to 35 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06464653 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of deep brain stimulation (DBS) targeting Forel's Field H as an adjunctive therapy for patients suffering from Lennox-Gastaut Syndrome. The study will enroll 5 participants aged 14 to 35 who experience persistent disabling seizures. It is designed as a prospective, interventional, unblinded, single-arm trial, aiming to provide new therapeutic options for this challenging condition. Participants will undergo a comprehensive preoperative evaluation to determine their suitability for the intervention.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14-35 with Lennox-Gastaut Syndrome experiencing frequent disabling seizures.

Not a fit: Patients with psychogenic non-epileptic seizures or those with existing implanted electrical devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option for patients with Lennox-Gastaut Syndrome who have not responded to traditional therapies.

How similar studies have performed: While deep brain stimulation has been explored in other contexts, this specific approach targeting Forel's Field H is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Participants are between the ages of 14 -35 years of age.
* Patients must be clinically evaluated as having Lennox-Gastaut syndrome.
* Persistence of disabling seizures at least 5 times per months or greater.
* After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
* Informed consent signed.

Exclusion Criteria:

* 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.);
* 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.

Where this trial is running

Beijing, Beijing

• Xuanwu Hospital,Capital Medical University — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Liankun Ren, MD — Xuanwu Hospital, Beijing
• Study coordinator: Liankun Ren, MD

Conditions Lennox Gastaut Syndrome; Deep Brain Stimulation; Lennox-Gastaut Syndrome; Forel's Field H