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
About this trial
This is an interventional treatment trial for Cluster Headache focused on measuring deep brain stimulation, cluster headache, hypothalamus
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
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
NCT ID
NCT00662935
First Posted
April 17, 2008
Last Updated
April 17, 2008
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Medtronic
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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