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Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.

NCT00200109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2011-10-12

No results posted yet for this study

Summary

Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month.

Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.

Conditions

  • Chronic Migraine Headache

Interventions

DEVICE

Occipital Nerve Stimulation

Each group had a different plan

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Joel Saper, M.D. · Michigan Head Pain and Neurological Institute, Ann Arbor, MI

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-06-30
Completion
2011-05-31

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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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 NCT00200109 on ClinicalTrials.gov