Occipital Nerve Stimulation in Medically Intractable Chronic Cluster Headache

Summary

Cluster headache (CH) is a primary headache disorder characterized by recurrent short-lasting attacks (15 to 180 minutes) of excruciating unilateral periorbital pain accompanied by ipsilateral cranial autonomic signs. The 1-year prevalence of CH is about 0.1 %, the male: female ratio is 3:1. The majority of patients have cluster periods of weeks to months with frequent attacks which are alternated with symptom-free periods of months to several years; the episodic from of CH. In about 10% of patients the CH is chronic (CCH) in which either no remission occurs within 1 year or the remissions last less than 1 month. At least 10 % of CCH patients are refractory to medical treatment or cannot tolerate the treatments.

Recent pilot studies suggest that occipital nerve stimulation (ONS) in medically intractable CCH (MICCH) might offer an effective alternative to medical treatment. There are no randomised clinical trials and a placebo effect cannot be excluded. Long term tolerability is known from other indications.

Here the investigators propose a prospective, randomised, double blind, parallel group multi-centre international clinical study to compare the reduction in attack frequency from baseline of occipital nerve stimulation (ONS) in patients with MICCH between two different stimulation conditions: high (100%) and low (30%) stimulation.

Following implantation there will first be a run-in phase of 10 days of 10% stimulation intensity, followed by a stepwise monthly increase up to either 30% or 100%. Patients will be assessed monthly by a blinded assessor. The primary outcome measure is the mean number of attacks over the last 4 weeks of the double blind 6 month treatment period in the 100% versus the 30% treatment group. Hereafter, in an open extension phase of 6 months, all patients will receive 100% stimulation or the stimulation considered optimal by the patient.

Secondary outcome measures include the rate of responders (≥ 50% reduction in attack frequency during the last 4 weeks of each treatment period), patient's satisfaction, medication use, quality of life, mean pain intensity, economic evaluation and whether patients would recommend the treatment to another patient. The investigators will also investigate whether predictive factors can be identified for efficacy.

Conditions

• Chronic Cluster Headache

Interventions

DEVICE

occipital nerve stimulation

Low occipital bilateral Quad Plus, midline to laterally directed, secured by titan anchors, connected to Versitrel. No trial stimulation. Suggested stimulation parameters: Pulse width: 450, Amplitude: protocol, Rate: 60

Sponsors & Collaborators

• Maastricht University Medical Center

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Technical University of Twente

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Centre Hospitalier Régional de la Citadelle

  collaborator OTHER

• Schmerzklinik Kiel

  collaborator UNKNOWN

• University Hospital Schleswig-Holstein

  collaborator OTHER

• National Institute of Neuroscience, Budapest

  collaborator UNKNOWN

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• Michel Ferrari, MD PhD · Leiden University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2018-09-30

Completion

2019-03-31

Countries

• Belgium
• Germany
• Hungary
• Netherlands

Study Locations