CClinicalTrials.gg
Sign In
CompletedNCT00407992MigraineUpdated Sep 23, 2019

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

An interventional study of Occipital nerve stimulation ON and Occipital nerve stimulation off in Headache, Migraine, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-23.

Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Headache, Migraine

Keywords

  • Headache
  • Migraine
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 34 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 36 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with migraine
  • patients 18 years aged or above

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Occipital nerve stimulation ON

    Device: Occipital nerve stimulation ON

  • Other
    Occipital nerve stimulation OFF

    Device: Occipital nerve stimulation off

Interventions

  • DeviceOccipital nerve stimulation ON

    Implant of an occipital nerve stimulator switched ON

  • DeviceOccipital nerve stimulation off

    Implant of an occipital nerve stimulator switched OFF

06

What researchers measure

Primary outcomes

  1. Number and the type of adverse events

    Time frame: Study period

  2. Reduction of headache frequency and intensity

    Time frame: Study period

Secondary outcomes

  1. Reduction in drug intake

    Time frame: Study period

  2. Changes in QoL and interference in everyday activities

    Time frame: Study period

07

Study locations

1 site
  • Ospedale Sacro Cuore - Don Calabria
    Negrar, Verona 37024, Italy
08

References and documents

Publications

  • Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53. PubMed 22622909 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00407992
Lead sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
Responsible party
Sponsor
First posted
Dec 5, 2006
Start date
Dec 2006
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Sep 23, 2019

Study contacts

Gerardo Serra
principal investigator · IRCCS Sacro Cuore Don Calabria di Negrar
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Migraine Disorders→

Other studies from this sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Start the discussion