Electrical Stimulation of Thalamus for Epilepsy of Lennox-Gastaut Phenotype (ESTEL)

Not Applicable

Completed

• Conditions: ennox-Gastaut Syndrome; Lennox-Gastaut Syndrome; Neurological - Epilepsy

• Registration Number: ACTRN12621001233819
• Lead Sponsor: Associate Professor John ARCHER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-01
• Study Start: 2021-09-13
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

i) an electroclinical diagnosis of LGS; ii) generalised paroxysmal fast activity (GPFA) and slow spike-and-wave (SSW) on interictal EEG; and iii) generalised tonic seizures documented on prior video-EEG monitoring or clearly described by a reliable eyewitness

Exclusion Criteria

i) participants with elevated risks for bleeding; ii) cerebral anatomical variations precluding safe CM-DBS implantation; iii) predominant seizure type being focal impaired awareness seizures; iv) current or prior psychogenic non-epileptic seizures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the proportion of participants with a >/= 50% reduction in diary-recorded seizures in stimulated versus control participants, measured at the end of the blinded phase. [month 6 post implantation = month 3 of blinded phase ]