Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH)
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Purpose
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 |
|---|---|
|
Cluster Headache |
Procedure: setting-up of an electrode in deep brain |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH) |
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 2
the sequence of stimulation begins by OFF
|
Procedure: setting-up of an electrode in deep brain
deep brain stimulation of the postero-inferoir hypothalamus
|
|
Experimental: 1
the sequence of stimulation begins by ON
|
Procedure: setting-up of an electrode in deep brain
deep brain stimulation of the postero-inferoir hypothalamus
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Principal Investigator: | Michel LANTERI-MINET, PhD | Department of Neurology, CHU de NIce |
| Principal Investigator: | Denys FONTAINE, PhD | Department of Neurology, CHU de Nice |
More Information
No publications provided by Centre Hospitalier Universitaire de Nice
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GIRAN Cynthia, Département de la Recherche Clinique et de l'Innovation |
| ClinicalTrials.gov Identifier: | NCT00662935 History of Changes |
| Other Study ID Numbers: | 04 -APN -03 |
| Study First Received: | April 17, 2008 |
| Last Updated: | April 17, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee |
Keywords provided by Centre Hospitalier Universitaire de Nice:
|
deep brain stimulation cluster headache hypothalamus |
Additional relevant MeSH terms:
|
Brain Diseases Cluster Headache Headache Trigeminal Autonomic Cephalalgias Headache Disorders, Primary Headache Disorders |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013