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

NCT00662935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2008-04-21

No results posted yet for this study

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.

Conditions

  • Cluster Headache

Interventions

PROCEDURE

setting-up of an electrode in deep brain

deep brain stimulation of the postero-inferoir hypothalamus

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Michel LANTERI-MINET, PhD · Department of Neurology, CHU de NIce

  • Denys FONTAINE, PhD · Department of Neurology, CHU de Nice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-01-31
Completion
2008-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662935 on ClinicalTrials.gov