Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431457
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2007-02-02
Brief Title:
Controlled Randomized Stimulation Versus Resection CoRaStiR
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Prospective Randomized Controlled Study of Neurostimulation in the Medial Temporal Lobe for Patients With Medically Refractory Medial Temporal Lobe Epilepsy Controlled Randomized Stimulation Versus Resection CoRaStiR
Status:
COMPLETED
Status Verified Date:
2023-01
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:
Patients will be prospectively randomized to 3 different treatment arms
Treatment group 1 patients who undergo medial temporal lobe resection
Treatment group 2 patients who receive immediate hippocampal neurostimulation
Treatment group 3 patients who are implanted with an intracranial electrode but in whom hippocampal neurostimulation is delayed for 6 months
Twelve months after inclusion unblinding will occur Patients in group 2 and 3 will have the option to choose between continuing neurostimulation treatment or resective surgery
Study visits will occur every 3 months
Treatment group 1 patients who undergo medial temporal lobe resection
Treatment group 2 patients who receive immediate hippocampal neurostimulation
Treatment group 3 patients who are implanted with an intracranial electrode but in whom hippocampal neurostimulation is delayed for 6 months
Twelve months after inclusion unblinding will occur Patients in group 2 and 3 will have the option to choose between continuing neurostimulation treatment or resective surgery
Study visits will occur every 3 months
Detailed Description:
None
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