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

NCT ID: NCT00662935

Last Updated: 2008-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Cluster Headache

Keywords

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deep brain stimulation cluster headache hypothalamus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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2

the sequence of stimulation begins by OFF

Group Type EXPERIMENTAL

setting-up of an electrode in deep brain

Intervention Type PROCEDURE

deep brain stimulation of the postero-inferoir hypothalamus

1

the sequence of stimulation begins by ON

Group Type EXPERIMENTAL

setting-up of an electrode in deep brain

Intervention Type PROCEDURE

deep brain stimulation of the postero-inferoir hypothalamus

Interventions

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setting-up of an electrode in deep brain

deep brain stimulation of the postero-inferoir hypothalamus

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Département de la Recherche Clinique et de l'Innovation

Principal Investigators

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Michel LANTERI-MINET, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, CHU de NIce

Denys FONTAINE, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, CHU de Nice

References

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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.

Reference Type DERIVED
PMID: 19936616 (View on PubMed)

Other Identifiers

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04 -APN -03

Identifier Type: -

Identifier Source: org_study_id