NCT06464653

Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

The Efficacy and Safety of Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome: A Prospective, Pilot Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Liankun_Ren · Academic / Other
• Sex: All
• Age: 14 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lennox Gastaut Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-06-18
• Last updated: 2026-04-13

Locations

1 site across 1 country: China