Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome

Lennox Gastaut Syndrome Clinical Trial

— FESL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464653
• Other study ID #: 2024-128-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: June 2024
• Source: Xuanwu Hospital, Beijing
• Contact: Liankun Ren, MD
• Phone: +86 13681576621
• Email: renlk2022[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 35 Years

Eligibility

Inclusion Criteria:

• Participants are between the ages of 14 -35 years of age.

• Patients must be clinically evaluated as having Lennox-Gastaut syndrome.

• 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:

• Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;

• 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.

Related Conditions & MeSH terms

• Lennox Gastaut Syndrome
• Syndrome

Intervention

Device:
• Forel's Field H-DBS ON
The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy. The targets used in this study is Forel's Field H. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.

Locations

Country	Name	City	State
China	Xuanwu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure Frequency (SF28)	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.	Up to 1 year after Forel's Field H-DBS
Secondary	Seizure Responder Rate	The proportion of patients with a = 50% reduction from Baseline in seizure frequency.	Up to 1 year after Forel's Field H-DBS
Secondary	Life quality evaluation	Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.	Up to 1 year after Forel's Field H-DBS
Secondary	Cognitive function evaluation (MMSE)	Percentage change from baseline in Mini-Mental State Examination (MMSE) score.	Up to 1 year after Forel's Field H-DBS
Secondary	Cognitive function evaluation (MoCA)	Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score.	Up to 1 year after Forel's Field H-DBS
Secondary	Adverse Events	Rate of adverse events which were judged to be study-related throughout the study.	Up to 1 year after Forel's Field H-DBS
Secondary	Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)	The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.	Up to 1 year after Forel's Field H-DBS