NCT02081482

Brief Summary

The occipital nerve stimulation (ONS) is used to treat patients with refractory primary chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have been suggested in particular a specific action on cerebral generators involved in different types of primary headaches or a non specific action on pain modulatory network. The aim of this study, using the chronic cluster headache as a model, is to determine the changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary chronic headache.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

March 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

March 4, 2014

Last Update Submit

March 18, 2016

Conditions

Refractory Chronic Cluster Headache

Outcome Measures

Primary Outcomes (1)

  • Comparison of cerebral metabolism

    Changes of cerebral metabolism associated with ONS efficacy

    Baseline (before ONS), 1 week after ONS , 3 month after ONS

Study Arms (1)

subjects with refractory chronic cluster headache

EXPERIMENTAL

Adult subjects with refractory chronic cluster headache and ONS indication

Radiation: 18F-FDG PET

Interventions

18F-FDG PETRADIATION
subjects with refractory chronic cluster headache

Eligibility Criteria

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

You may qualify if:

  • age \> 18 years
  • chronic cluster headache (according to the IHS)
  • refractory in who a treatment by ONS have been indicated
  • patient affiliated at social security,
  • informed consent signed

You may not qualify if:

  • contraindication to MRI
  • contraindication to 18F-FDG PET
  • women without contraception/pregnant/breast-feeding
  • patient non-compliant
  • patient on legal guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU -Hôpital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Institut des Neurosciences

Marseille, 13385, France

Location

Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice

Nice, 06000, France

Location

Centre d'Urgence Céphalées

Paris, 75010, France

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 7, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2016

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

FR(4)