NCT00407992

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

December 4, 2006

Last Update Submit

September 19, 2019

Conditions

Headache, Migraine

Keywords

HeadacheMigraine

Outcome Measures

Primary Outcomes (2)

  • Number and the type of adverse events

    Study period

  • Reduction of headache frequency and intensity

    Study period

Secondary Outcomes (2)

  • Reduction in drug intake

    Study period

  • Changes in QoL and interference in everyday activities

    Study period

Study Arms (2)

Occipital nerve stimulation ON

EXPERIMENTAL
Device: Occipital nerve stimulation ON

Occipital nerve stimulation OFF

OTHER
Device: Occipital nerve stimulation off

Interventions

Occipital nerve stimulation ONDEVICE

Implant of an occipital nerve stimulator switched ON

Occipital nerve stimulation ON
Occipital nerve stimulation offDEVICE

Implant of an occipital nerve stimulator switched OFF

Occipital nerve stimulation OFF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with migraine
  • patients 18 years aged or above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Sacro Cuore - Don Calabria

Negrar, Verona, 37024, Italy

Location

Related Publications (1)

  • Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53.

    PMID: 22622909RESULT

MeSH Terms

Conditions

Migraine DisordersHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gerardo Serra

    IRCCS Sacro Cuore Don Calabria di Negrar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

December 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

IT(1)