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Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

TerminatedNot applicableNCT01775735
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.

Study details

Official title
Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
Interventions
  • Device: Occipital nerve stimulator
Sponsor
Boston Scientific Corporation
Start date
2013-04-10
Primary completion
2015-12-01
Sex
All
Age range
from 21 Years to 75 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
10

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Key Inclusion Criteria: * Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history * Evidence of intractability * Posterior-dominant head pain * Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening * Onset of migraine before the age of 50 * If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test Key Exclusion Criteria: * Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia) * Untreated panic disorder * Untreated major depression evidenced by a PHQ-9 score \>20 * Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15 * Currently diagnosed with severe personality disorder * A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception * Participating in another drug, device, or biologics trial within 3 months prior to Screening * A terminal illness associated with survival \<24 months

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01775735