Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

• Change in the number of moderate-to-severe headache days per month [ Time Frame: from Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]

  A moderate-to-severe headache day will be defined as any calendar day with:

  1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity

     OR

  2. a subject taking a triptan or ergot, regardless of headache pain duration or severity

  The Baseline number will be calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries. The 6 months post-randomization number will be calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit.

  
  

• Moderate-to-severe headache frequency response [ Time Frame: 6 months post-randomization ] [ Designated as safety issue: No ]
  A responder will be defined as any subject achieving ≥50% reduction in the total count of moderate-to-severe headache days from the first 30 calendar days of eDiary entries to the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit.
  
  
• Conversion to <15 moderate-to-severe headache days per month [ Time Frame: 6 months post-randomization ] [ Designated as safety issue: No ]
  A conversion subject will be defined as any subject with <15 total count of moderate-to-severe headache days during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit.
  
  
• Change in average number of moderate-to-severe headache hours per day [ Time Frame: from Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]
  The number of moderate-to-severe headache hours for a given day will be defined as the number of hours in the corresponding eDiary entry that the subject spent with a headache with a peak intensity of moderate or severe. A calendar day with a peak intensity of mild will have 0 moderate-to-severe headache hours.
  
  
• Change in daily headache intensity [ Time Frame: from Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]
  Daily headache intensity will be calculated based on the Average Intensity question, collected using the eDiary, starting at the beginning of the 30-day Baseline eDiary period and ending at 6 months post-randomization.
  
  
• Headache intensity response (30%) [ Time Frame: 6 months post-randomization ] [ Designated as safety issue: No ]
  For this endpoint, a responder will be defined as any subject achieving ≥30% reduction in daily headache intensity from the first 30 calendar days of eDiary entries to the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit.
  
  
• Change in headache impact [ Time Frame: from Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]
  Headache impact will be based on headache impact test (HIT-6) questionnaire, completed by the subject at the Baseline and 6-Month Visits.
  
  
• Change in migraine-specific quality of life [ Time Frame: from Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]
  Migraine-specific quality-of-life (MSQ) will be based on MSQ v2.1 questionnaire completed by the subject at the Baseline and 6-Month Visits.
  
  
• Subject satisfaction with treatment [ Time Frame: 6 months post-randomization ] [ Designated as safety issue: No ]
  Subject satisfaction with treatment will be based on a modified treatment satisfaction questionnaire (TSQM-9) completed by the subject at the Baseline and 6-Month Visits. Subject satisfaction with treatment will be calculated as the total TSQM-9 score across all the domains of the questionnaire.
  
  
• Rate of adverse events (AEs) [ Time Frame: 6 months post-randomization ] [ Designated as safety issue: Yes ]
  An adverse event is any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device.
  
  

Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).