Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00662935
First received: April 17, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

The aim of this study is to evaluate the efficacy and safety of deep brain stimulation (DBS) in chronic and treatment-resistant CH. Inclusion criteria are: patients with chronic CH (>3years), with daily attack and non response to adequate treatment. Electrodes are implanted stereotactically in the postero-inferior hypothalamus. In this crossover, randomized, placebo-controlled double-blinded study, the efficacy of DBS is evaluated using comparison of two one-month sequences: one with stimulation "on" and the other with stimulation "off" (placebo sequence). Efficacy is defined as ≥50% decrease of weekly frequency of CH attacks. After the randomized period, long-term efficacy and safety are evaluated after one year of stimulation in open conditions.


Condition Intervention
Cluster Headache
Procedure: setting-up of an electrode in deep brain

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Decrease (≥50% by reference to a prospective pre-implantation run-in period) of the weekly frequency of cluster headache attacks between treatment and placebo one-month sequences. [ Time Frame: between treatment and placebo one-month sequences. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensity of dysautomic dysfunction, acute treatment consumption, quality of life Between treatment and placebo one-month sequences. [ Time Frame: Between treatment and placebo one-month sequences. ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2005
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
the sequence of stimulation begins by OFF
Procedure: setting-up of an electrode in deep brain
deep brain stimulation of the postero-inferoir hypothalamus
Experimental: 1
the sequence of stimulation begins by ON
Procedure: setting-up of an electrode in deep brain
deep brain stimulation of the postero-inferoir hypothalamus

Detailed Description:

Over the past 7 years, deep brain stimulation (DBS) has been used in various centres to treat patients with intractable chronic cluster headache (CH). Results in these non-controlled studies were encouraging but need to be confirmed in controlled conditions. The aim of this study is to evaluate the efficacy and safety of DBS in chronic and treatment-resistant CH, in randomized placebo-controlled conditions.

Inclusion criteria are: patients with chronic CH (>3years), with daily attack and non response to adequate treatment (verapamil up 960 mg/d, lithium with plasmatic level 0.6-1 mEq/ ml, and association of both drugs). After induction of local anaesthesia, electrodes are implanted stereotactically in the postero-inferior hypothalamus according to the previously described coordinates, and connected to a sub-cutaneous generator. In this crossover, randomized, placebo-controlled double-blinded study, the efficacy of DBS is evaluated using comparison of two one-month sequences: one with stimulation "on" and the other with stimulation "off" (considered as the placebo sequence). Primary efficacy is defined as ≥50% decrease of weekly frequency of CH attacks, compared to a prospective run-in pre-implantation period. Safety and tolerability are clinically and biologically assessed. After the randomized period, long-term efficacy and safety are evaluated after one year of stimulation in open conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between 18 and 65 year old
  • suffering from cluster headache since 3 years at least
  • not responding to others treatments such as : verapamil, lithium or both of them

Exclusion Criteria:

  • patient with addiction
  • pregnancy or feeding women
  • contraindication to general anesthetic
  • contraindication to MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662935

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Medtronic
Investigators
Principal Investigator: Michel LANTERI-MINET, PhD Department of Neurology, CHU de NIce
Principal Investigator: Denys FONTAINE, PhD Department of Neurology, CHU de Nice
  More Information

No publications provided by Centre Hospitalier Universitaire de Nice

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GIRAN Cynthia, Département de la Recherche Clinique et de l'Innovation
ClinicalTrials.gov Identifier: NCT00662935     History of Changes
Other Study ID Numbers: 04 -APN -03
Study First Received: April 17, 2008
Last Updated: April 17, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
deep brain stimulation
cluster headache
hypothalamus

Additional relevant MeSH terms:
Brain Diseases
Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014