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French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01842763
Acronym
NGO
Enrollment
246
Registered
2013-04-30
Start date
2013-03-31
Completion date
2027-09-30
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Chronic Headache Disorders

Keywords

Chronic daily headache, treated by occipital nerves stimulation, peripheral neuromodulation, occipital nerves, network, database

Brief summary

The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by occipital nerves stimulation. Every team using this neuromodulation approach in France is likely to participate in the network. Fifty patients a year are expected. They will be informed about data which are collected and why they are collected. The data will come from medical files and questionnaires filling out by the patients. The data will be collected on a case report form adapted to each refractory chronic headache disorder. The case report form pages will be faxed to the coordinating team who will enter the data in the database and analyse the data in a descriptive manner. These data are social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data. This research should provide an update on practices, an evaluation of the efficacy and long term safety of occipital nerves stimulation, and perhaps help in identifying response predictive factors to this neuromodulation approach.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patients suffering from refractory chronic headache disorders and treated by occipital nerves stimulation

Exclusion criteria

* patients who don't agree with participating in the study because the ending of professional confidentiality is required for setting up the database

Design outcomes

Primary

MeasureTime frameDescription
observation of a disease or medical condition under normal conditionsat each visit (up to 4 years)social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026