Viewing Study NCT04102254



Ignite Creation Date: 2024-05-06 @ 1:43 PM
Last Modification Date: 2024-10-26 @ 1:18 PM
Study NCT ID: NCT04102254
Status: WITHDRAWN
Last Update Posted: 2022-08-25
First Post: 2019-09-23

Brief Title: Thalamic Stimulation for Epilepsy Study
Sponsor: Duke University
Organization: Duke University

Study Overview

Official Title: Thalamic Stimulation for Epilepsy Study
Status: WITHDRAWN
Status Verified Date: 2022-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Lead acquisition from company COVID-19 restrictions
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In this study the investigator aims to perform cortical stereo electroencephalogram sEEG recordings during simultaneous anterior nucleus of the thalamus ANT recording and stimulation to better understand the following 1 how the ANT is involved in various seizure types 2 which cortical regions are modulated by established ANT stimulation patterns and 3 how novel ANT stimulation patterns modify epileptogenic cortical activity Together this knowledge will advance ANT deep brain stimulation DBS therapy by providing a physiologic basis for patient selection for ANT DBS while identifying brain signals and stimulation patterns that can be used to develop novel methods for ANT DBS Up to 15 adult patients 18 and older who present to Duke Neurosurgery for routine seizure localization using sEEG will be asked to enroll in this pilot study of ANT recording and stimulation In the course of surgical epilepsy treatment patients routinely undergo surgical placement of sEEG electrodes for the purposes of seizure localization During this procedure 2 additional leads will be placed in the ANT These patients remain hospitalized for 7-14 days after sEEG placement during which time their seizure medications are tapered Concurrent video monitoring is performed while continuous neural recordings are made through the sEEG electrodes Additionally continuous recordings will be performed through the electrodes placed in the thalamus Periodically standard intermittent high-frequency stimulation 130 Hz 90-ms pulse width and 2 mA intensity will be performed with a 60-s on and a 300-s off cycle after surgery These standard ANT stimulation parameters are employed clinically Data will include the sEEG recordings marked for ANT stimulation any side effects medications past medical history PMH and testsprocedures during the hospital stay Risks involved are as described for the standard depth electrode surgery with the addition of the possible side effects from the stimulation which include sensations of numbness and tingling and possibly increased seizure activity
Detailed Description: The purpose of this research is to examine the physiologic underpinnings of deep brain stimulation of the anterior nucleus of the thalamus ANT a method reducing seizures in adults diagnosed with medically refractory epilepsy In this study the investigator aims to perform cortical stereo electroencephalogram sEEG recordings during simultaneous ANT recording and stimulation to better understand the following 1 how the ANT is involved in various seizure types 2 which cortical regions are modulated by established ANT stimulation patterns and 3 how novel ANT stimulation patterns modify epileptogenic cortical activity Together this knowledge will advance ANT DBS therapy by providing a physiologic basis for patient selection for ANT DBS while identifying brain signals and stimulation patterns that can be used to develop novel methods for ANT DBS

Approximately 3 million people in the United States experience epilepsy Despite medical therapy up to 30 of these patients continue to experience recurrent seizures In this medically refractory population tissue resection or ablation offer a high likelihood of seizure freedom if a single epileptogenic focus can be precisely identified For patients who are not candidates for resection or ablation or those who continue to have seizures after these treatments neuromodulation represents an alternative therapeutic option One such therapy deep brain stimulation DBS has been approved for around 5 years in Europe and was recently approved in the United States as a treatment for medically refractory epilepsy

A number of potential DBS targets are being investigated particularly the ANT which consists of the anteroventral anterodorsal and anteromedial nuclei The ANT was recognized as a potential target because of its central connectivity to cortical regions where seizures often originate Several pilot studies and recent trials have demonstrated 5-year efficacy and safety outcomes for ANT DBS In a large randomized controlled study of ANT stimulation with long-term follow-up there was a 56 median seizure reduction at the 2 year and a 69 median and seizure reduction at the 5 year in patients with drug-resistant focal epilepsy This study also suggested that patients with temporal lobe epilepsy achieved greater benefit than those with extra-temporal or multifocal seizures Since these pivotal trials DBS of the ANT has emerged as a promising therapy for focal drug resistant epilepsy however its basic mechanism of action is unclear One study which examined cortical local field potentials recordings during high-frequency ANT stimulation 130 Hz has suggested that epileptic network desynchronization is a potential mechanism of DBS of the ANT

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None