Clinical trial NCT00662935: Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH)
Official title: Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cluster Headache
Keywords: deep brain stimulation
cluster headache
hypothalamus
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2008-04-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: between treatment and placebo one-month sequences.
Secondary outcomes:
measure: Intensity of dysautomic dysfunction, acute treatment consumption, quality of life Between treatment and placebo one-month sequences.
timeFrame: Between treatment and placebo one-month sequences.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurology, CHU de NIce
name: Michel LANTERI-MINET, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, CHU de Nice
name: Denys FONTAINE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.