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Sponsors and Collaborators: |
Centre Hospitalier Universitaire de Nice Medtronic |
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Information provided by: | Centre Hospitalier Universitaire de Nice |
ClinicalTrials.gov Identifier: | NCT00662935 |
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 |
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Cluster Headache |
Procedure: setting-up of an electrode in deep brain |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH) |
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 |
---|---|
2: Experimental
the sequence of stimulation begins by OFF
|
Procedure: setting-up of an electrode in deep brain
deep brain stimulation of the postero-inferoir hypothalamus
|
1: Experimental
the sequence of stimulation begins by ON
|
Procedure: setting-up of an electrode in deep brain
deep brain stimulation of the postero-inferoir hypothalamus
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Michel LANTERI-MINET, PhD | Department of Neurology, CHU de NIce |
Principal Investigator: | Denys FONTAINE, PhD | Department of Neurology, CHU de Nice |
Responsible Party: | Département de la Recherche Clinique et de l'Innovation ( GIRAN Cynthia ) |
Study ID Numbers: | 04 -APN -03 |
Study First Received: | April 17, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00662935 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee |
deep brain stimulation cluster headache hypothalamus |
Cluster Headache Signs and Symptoms Headache Neurologic Manifestations Central Nervous System Diseases |
Pain Headache Disorders, Primary Brain Diseases Headache Disorders |
Trigeminal Autonomic Cephalalgias Nervous System Diseases |