Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200109
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2005-09-12
Brief Title:
Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache
Sponsor:
MedtronicNeuro
Organization:
MedtronicNeuro
Study Overview
Official Title:
ONSTIM Occipital Nerve Stimulation for the Treatment of Intractable Migraine
Status:
COMPLETED
Status Verified Date:
2011-10
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:
ONSTIM
Brief Summary:
Background Medically intractable chronic migraine CM is a disabling illness characterized by headache greater than 15 days per month
Method A multicenter randomized blinded controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation ONS in CM Eligible subjects received an occipital nerve block and responsers were randomized to adjustable stimulation AS preset stimulation PS or medical management MM groups
Method A multicenter randomized blinded controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation ONS in CM Eligible subjects received an occipital nerve block and responsers were randomized to adjustable stimulation AS preset stimulation PS or medical management MM groups
Detailed Description:
The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head
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