Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome

Launched by XUANWU HOSPITAL, BEIJING · Jun 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called deep brain stimulation (DBS) aimed at helping people with Lennox-Gastaut Syndrome, a severe type of epilepsy that causes frequent seizures. The researchers want to find out if stimulating a specific area in the brain, known as Forel's Field H, can reduce the number and severity of seizures for patients who still experience disabling seizures despite other treatments. The trial is currently looking for participants aged 14 to 35 who have been diagnosed with Lennox-Gastaut Syndrome and have at least five seizures a month.

To be eligible, participants should have had a thorough evaluation and should not be suitable for surgery to remove the source of their seizures. However, certain individuals, such as those with specific types of epilepsy or serious medical conditions, will not be able to join. If you participate, you can expect to receive this new treatment while being closely monitored for its effectiveness and safety. This trial represents an opportunity to explore a potential new option for managing seizures in a challenging condition.

Gender

ALL

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.