Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 5:25 PM
Study NCT ID:
NCT00431457
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2007-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Randomized Stimulation Versus Resection (CoRaStiR)
Sponsor:
University Hospital, Ghent
Organization:
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:
False
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?: