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

Primary Purpose

Cluster Headache

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
setting-up of an electrode in deep brain
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cluster Headache focused on measuring deep brain stimulation, cluster headache, hypothalamus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    2

    1

    Arm Description

    the sequence of stimulation begins by OFF

    the sequence of stimulation begins by ON

    Outcomes

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 17, 2008
    Last Updated
    April 17, 2008
    Sponsor
    Centre Hospitalier Universitaire de Nice
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00662935
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice
    Collaborators
    Medtronic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cluster Headache
    Keywords
    deep brain stimulation, cluster headache, hypothalamus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    the sequence of stimulation begins by OFF
    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    the sequence of stimulation begins by ON
    Intervention Type
    Procedure
    Intervention Name(s)
    setting-up of an electrode in deep brain
    Intervention Description
    deep brain stimulation of the postero-inferoir hypothalamus
    Primary Outcome Measure Information:
    Title
    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.
    Secondary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michel LANTERI-MINET, PhD
    Organizational Affiliation
    Department of Neurology, CHU de NIce
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Denys FONTAINE, PhD
    Organizational Affiliation
    Department of Neurology, CHU de Nice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19936616
    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.
    Results Reference
    derived

    Learn more about this trial

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

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