Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome
- Conditions
- Lennox Gastaut Syndrome
- Interventions
- Device: Forel's Field H-DBS ON
- Registration Number
- NCT06464653
- Lead Sponsor
- Xuanwu Hospital, Beijing
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Forel's Field H-DBS group Forel's Field H-DBS ON participants will undergo Forel's Field H-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.
- Primary Outcome Measures
Name Time Method Seizure Frequency (SF28) 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.
- Secondary Outcome Measures
Name Time Method Life quality evaluation Up to 1 year after Forel's Field H-DBS 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.
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) Up to 1 year after Forel's Field H-DBS The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.
Seizure Responder Rate Up to 1 year after Forel's Field H-DBS The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Cognitive function evaluation (MMSE) Up to 1 year after Forel's Field H-DBS 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.
Adverse Events Up to 1 year after Forel's Field H-DBS Rate of adverse events which were judged to be study-related throughout the study.
Cognitive function evaluation (MoCA) Up to 1 year after Forel's Field H-DBS 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.
Trial Locations
- Locations (1)
Xuanwu Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China