Clinical trial NCT06464653: Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome
Official title: The Efficacy and Safety of Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome: a Prospective, Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lennox Gastaut Syndrome
Keywords: Deep Brain Stimulation
Lennox-Gastaut Syndrome
Forel's Field H
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 5
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Forel's Field H 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 Forel's Field H 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.

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.

Primary outcomes:
measure: Seizure Frequency (SF28)
timeFrame: Up to 1 year after Forel's Field H-DBS
Secondary outcomes:
measure: Seizure Responder Rate
timeFrame: Up to 1 year after Forel's Field H-DBS
measure: Life quality evaluation
timeFrame: Up to 1 year after Forel's Field H-DBS
measure: Cognitive function evaluation (MMSE)
timeFrame: Up to 1 year after Forel's Field H-DBS
measure: Cognitive function evaluation (MoCA)
timeFrame: Up to 1 year after Forel's Field H-DBS
measure: Adverse Events
timeFrame: Up to 1 year after Forel's Field H-DBS
measure: Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
timeFrame: Up to 1 year after Forel's Field H-DBS
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liankun Ren, MD
role: PRINCIPAL_INVESTIGATOR
References: