Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

NCT01184222 | Completed

• 1 other identifier: 02-API-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.

Conditions

HEADACHE

Outcome Measures

Primary Outcomes (1)

• Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham)

  14 days

Secondary Outcomes (4)

• number of headache days during the 14 days withdrawal period

  14 days

• maximal intensity and duration of rebound headache

  14 days

• rescue medication used

  14 days

• withdrawal facility perceived by the patient

  14 days

Study Arms (2)

Arm Active SENGO

ACTIVE COMPARATOR

The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.

Device: great occipital nerve stimulation

Arm sham SENGO

PLACEBO COMPARATOR

The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.

Device: great occipital nerve stimulation

Interventions

great occipital nerve stimulation DEVICE

* Active Comparator: Arm Active SENGO The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted. * Arm sham SENGO : The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.

Arm Active SENGO; Arm sham SENGO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years old
• migraine patient with medication overuse headache by non specific analgesics according to the ICHD-II diagnostic criteria
• failure of outpatient withdrawal
• Signature of informed consent.
• Affiliation to French national health and pensions organization

You may not qualify if:

• pregnancy (positive pregnancy test at pre-study) and breast-feeding
• patients with medication overuse headache by specific antimigraine treatment (triptans or/and ergot derivatives) according to the ICHD-II diagnostic criteria
• previous surgical treatment targeting great occipital nerves

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (4)

Neurology department - La timone

Marseille, France

Location

Neurosurvery department

Nice, France

Location

Headache Emergency Center

Paris, France

Location

Neurology department - CHU Rangueil

Toulouse, France

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• FONTAINE Denys, PhD

  Neurosurgery depatment - CHU Pasteur, Nice

  STUDY CHAIR

• LANTERI-MINET Michet, PhD

  Neurosurgery department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: August 18, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2012
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

FR (4)