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

NCT00662935 | Completed

• 1 other identifier: 04 -APN -03
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cluster Headache

Keywords

deep brain stimulation; cluster headache; hypothalamus

Outcome Measures

Primary Outcomes (1)

• 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.

  between treatment and placebo one-month sequences.

Secondary Outcomes (1)

• Intensity of dysautomic dysfunction, acute treatment consumption, quality of life Between treatment and placebo one-month sequences.

  Between treatment and placebo one-month sequences.

Study Arms (2)

2

EXPERIMENTAL

the sequence of stimulation begins by OFF

Procedure: setting-up of an electrode in deep brain

1

EXPERIMENTAL

the sequence of stimulation begins by ON

Procedure: setting-up of an electrode in deep brain

Interventions

setting-up of an electrode in deep brain PROCEDURE

deep brain stimulation of the postero-inferoir hypothalamus

1; 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• patient with addiction
• pregnancy or feeding women
• contraindication to general anesthetic
• contraindication to MRI

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Medtronic: collaborator

Related Publications (1)

• Fontaine D, Lazorthes Y, Mertens P, Blond S, Geraud G, Fabre N, Navez M, Lucas C, Dubois F, Gonfrier S, Paquis P, Lanteri-Minet M. Safety and efficacy of deep brain stimulation in refractory cluster headache: a randomized placebo-controlled double-blind trial followed by a 1-year open extension. J Headache Pain. 2010 Feb;11(1):23-31. doi: 10.1007/s10194-009-0169-4.

  PMID: 19936616 DERIVED

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michel LANTERI-MINET, PhD

  Department of Neurology, CHU de NIce

  PRINCIPAL INVESTIGATOR

• Denys FONTAINE, PhD

  Department of Neurology, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: May 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 21, 2008

Record last verified: 2008-04