Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122915
Status:
TERMINATED
Last Update Posted:
2018-02-23
First Post:
2005-07-21
Brief Title:
CONCEPT Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
Sponsor:
MedtronicNeuro
Organization:
MedtronicNeuro
Study Overview
Official Title:
A Prospective Randomized Double Blind Crossover Multi-center Study to Evaluate the Safety and the Efficacy of Motor Cortex Stimulation With the Cortical Stimulation Lead Model 2976 in Patients With Neuropathic Pain
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on a consistently low enrolment rate and procedural challenges that were unknown at study start It was not based on safety or efficacy concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation MCS with a new cortical lead circular lead eight electrodes Medtronic Inc Minneapolis USA in the treatment of intractable neuropathic pain in particular for central post-stroke pain CPSP and trigeminal neuropathic pain TGNfacial pain
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