An Italian Randomized Open-label Study of Occipital Nerve... | NCT00407992

Studies
An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

NCT00407992

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Status

Completed

Last Update Posted

Sep 23, 2019Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Headache, Migraine

Interventions

Occipital nerve stimulation ON
Occipital nerve stimulation off

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 4, 2006

First Submission Date that Met QC Criteria

Dec 4, 2006

First Posted Date

Dec 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2019

Last Update Posted Date

Sep 23, 2019Actual

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Occipital nerve stimulation ON	Experimental		Device: Occipital nerve stimulation ON
Occipital nerve stimulation OFF	Other		Device: Occipital nerve stimulation off

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Occipital nerve stimulation ON	Device	Implant of an occipital nerve stimulator switched ON	Occipital nerve stimulation ON

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and the type of adverse events		Study period
Reduction of headache frequency and intensity		Study period

Secondary Outcomes

Measure	Description	Time Frame
Reduction in drug intake		Study period
Changes in QoL and interference in everyday activities		Study period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with migraine
patients 18 years aged or above

Exclusion Criteria:

patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
patients pregnant or planning on becoming pregnant during the study period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerardo Serra	IRCCS Sacro Cuore Don Calabria di Negrar	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Sacro Cuore - Don Calabria		Negrar	Verona	37024	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22622909	Result	Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53.

ID	Term
D008881	Migraine Disorders
D006261	Headache

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases