Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101933
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2005-01-18
Brief Title:
SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Sponsor:
MedtronicNeuro
Organization:
MedtronicNeuro
Study Overview
Official Title:
SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to study the safety and effectiveness of bilateral stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures with or without secondary generalization that are refractory to antiepileptic medications
Detailed Description:
Medtronic Inc is sponsoring an investigational study of the Medtronic DBS Therapy for epilepsy the companys deep brain stimulation DBS therapy for patients with refractory epilepsy Epilepsy is a condition that affects 23 million Americans and about one-third of these patients are refractory or continue to experience seizures despite a wide range of treatment options
The prospective randomized double-blind trial uses existing technology to test whether bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively reduce seizure frequency in patients with epilepsy It includes enrollment of 157 patients at 17 sites in the US 110 patients were implanted and monitored for 13 months following implant with long-term follow-up until the device is approved or the study is stopped 109 of the 110 implanted subjects were randomized to Active stimulation or Control
Patients in the active group who received neurostimulation were monitored for a reduction in seizure rates compared to the control group who did not receive neurostimulation during the three-month double-blind phase After the double-blind phase all patients received neurostimulation
Candidates for the trial were adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective They were to have had an average of six or more seizures per month Candidates continued to receive their epilepsy medications while participating in the trial
Deep brain stimulation therapy has already received approval in the United States Europe Canada and Australia for the treatment of Essential Tremor and Parkinsons disease Deep brain stimulation is not approved in the United States for the treatment of epilepsy
The prospective randomized double-blind trial uses existing technology to test whether bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively reduce seizure frequency in patients with epilepsy It includes enrollment of 157 patients at 17 sites in the US 110 patients were implanted and monitored for 13 months following implant with long-term follow-up until the device is approved or the study is stopped 109 of the 110 implanted subjects were randomized to Active stimulation or Control
Patients in the active group who received neurostimulation were monitored for a reduction in seizure rates compared to the control group who did not receive neurostimulation during the three-month double-blind phase After the double-blind phase all patients received neurostimulation
Candidates for the trial were adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective They were to have had an average of six or more seizures per month Candidates continued to receive their epilepsy medications while participating in the trial
Deep brain stimulation therapy has already received approval in the United States Europe Canada and Australia for the treatment of Essential Tremor and Parkinsons disease Deep brain stimulation is not approved in the United States for the treatment of epilepsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None