Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT01554332
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Cortex Stimulation for Chronic Neuropathic Pain
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
A Clinical Evaluation for the Management of Patients With Chronic Neuropathic Pain With Cortical Stimulation
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study is to evaluate the efficacy of cortical stimulation (CS) as an adjunctive treatment for chronic neuropathic pain.
Detailed Description:
Prospective, controlled, double blind, randomized, crossover study with endpoint evaluations at the end of each 3-month treatment period.
An interim analysis will be conducted by a blinded committee when approximately half of the patients have finished the study.
An interim analysis will be conducted by a blinded committee when approximately half of the patients have finished the study.
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?: