The Efficacy and Safety of Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome: A Prospective, Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Liankun_Ren
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Seizure Frequency (SF28)
Study Overview
Brief Summary
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of pallidothalamic tracts 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 pallidothalamic tracts 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meets the diagnostic criteria for Lennox-Gastaut Syndrome (LGS) based on comprehensive assessment of medical history, seizure semiology, and electroencephalographic (EEG) findings during both ictal and interictal periods;
- •Interictal EEG demonstrates generalized paroxysmal fast activity (GPFA) and slow spike-and-wave (SSW) complexes;
- •Generalized tonic-clonic seizures (GTCs) have been captured in prior video-EEG monitoring, or seizure episodes have been clearly described by reliable eyewitnesses;
- •During the screening or baseline period, the following conditions are met:
- •The patient or caregiver is capable of reliably maintaining a seizure diary;
- •The seizure diary indicates an average of at least 5 seizures per month;
- •The patient is on two or more antiepileptic drugs (AEDs), with a stable treatment regimen (no new add-on or withdrawal of AEDs, excluding temporary rescue medications such as benzodiazepines; dose adjustments are allowed);
- •The patient has been evaluated through a comprehensive presurgical epilepsy workup and is considered unsuitable for, or has declined, resective epilepsy surgery, or has had unsatisfactory outcomes from resective or ablative procedures;
- •Providation of written informed consent, demonstrates adequate compliance with the study protocol, and agrees to participate in this clinical study.
Exclusion Criteria
- •Unable to provide a reliable seizure diary by self or legal guardian;
- •Predominant seizure type is focal impaired awareness seizures;
- •Psychogenic non-epileptic seizures within 12 months;
- •Brain structual abnormalities precluding safe implantation of deep brain stimulator;
- •Conditions associated with increased risk of intraoperative or postoperative bleeding (e.g., coagulopathy), or requirement for long-term oral anticoagulant or antiplatelet therapy;
- •Presence of other severe somatic or internal medical conditions, including significant hepatic or renal dysfunction;
- •Pregnant, or planning to pregnant within 2 years.
Arms & Interventions
Pallidothalamic Tracts-DBS group
participants will undergo Pallidothalamic Tracts-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.
Intervention: Forel's Field H-DBS ON (Device)
Outcomes
Primary Outcomes
Seizure Frequency (SF28)
Time Frame: 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 Outcomes
- Adverse Events(Up to 1 year after Pallidothalamic Tracts-DBS)
- Life quality evaluation(Up to 1 year after Forel's Field H-DBS)
- Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)(Up to 1 year after Forel's Field H-DBS)
- Seizure Responder Rate(Up to 1 year after Forel's Field H-DBS)
- Cognitive function evaluation (MMSE)(Up to 1 year after Forel's Field H-DBS)
- Cognitive function evaluation (MoCA)(Up to 1 year after Forel's Field H-DBS)
Investigators
Liankun_Ren
Professor
Xuanwu Hospital, Beijing