An interventional study of Occipital nerve stimulator in Migraine Disorders, sponsored by Boston Scientific Corporation. Terminated at 10 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-13.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
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.
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).
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 28 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
Device: Occipital nerve stimulator
The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
Device: Occipital nerve stimulator
Electrical stimulation of the greater occipital nerve
Also known as: Boston Scientific Precision System
Change in the Number of Moderate-to-severe Headache Days Per Month
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 was 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 if the eDiary contained ≥70% of data. The 6 months post-randomization number was 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 if the eDiary contained ≥70% of data.
Time frame: from Baseline to 6 months post-randomization
| Milestone | Treatment | Control |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 7 |
| Not completed | 0 | 0 |
| Milestone | Treatment | Control |
|---|---|---|
| Started | 8 | 7 |
| Completed | 7 | 3 |
| Not completed | 1 | 4 |
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 was 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 if the eDiary contained ≥70% of data. The 6 months post-randomization number was 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 if the eDiary contained ≥70% of data.
| days | Treatment | Control |
|---|---|---|
| Change in the Number of Moderate-to-severe Headache Days Per Month | -5.2 ± 7.3 | 0 ± 10.8 |
Collected over Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/8 (0%) | 4/8 (50%) | 3/8 (37.5%) |
| Control | 0/7 (0%) | 1/7 (14.3%) | 3/7 (42.9%) |
| Event | Treatment | Control |
|---|---|---|
| Status migrainosusNervous system disorders | 2/8 | 0/7 |
| Adverse drug reactionGeneral disorders | 2/8 | 0/7 |
| ThrombosisVascular disorders | 0/8 | 1/7 |
| MigraineNervous system disorders | 1/8 | 0/7 |
| Hemiplegic migraineNervous system disorders | 1/8 | 0/7 |
| Migraine without auraNervous system disorders | 1/8 | 0/7 |
| CellulitisInfections and infestations | 1/8 | 0/7 |
| Wound dehiscenceInjury, poisoning and procedural complications | 1/8 | 0/7 |
| NephrolithiasisRenal and urinary disorders | 1/8 | 0/7 |
| Device related infectionInfections and infestations | 1/8 | 0/7 |
| Event | Treatment | Control |
|---|---|---|
| Implant site irritationGeneral disorders | 1/8 | 1/7 |
| MigraineNervous system disorders | 0/8 | 1/7 |
| Carpal tunnel syndromeNervous system disorders | 0/8 | 1/7 |
| Impaired healingGeneral disorders | 0/8 | 1/7 |
| DiverticulitisInfections and infestations | 0/8 | 1/7 |
| Myofascial pain syndromeMusculoskeletal and connective tissue disorders | 0/8 | 1/7 |
| Rotator cuff syndromeMusculoskeletal and connective tissue disorders | 0/8 | 1/7 |
| PneumoniaInfections and infestations | 1/8 | 0/7 |
| Upper respiratory tract infectionInfections and infestations | 1/8 | 0/7 |
| Surgical skin tearInjury, poisoning and procedural complications | 1/8 | 0/7 |
Randomized subjects
| Age, Categorical(Participants) | Treatment | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 7 | 14 |
| >=65 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Race/Ethnicity — American Indian or Alaska native | 0 | 0 | 0 |
| Race/Ethnicity — Asian | 0 | 0 | 0 |
| Race/Ethnicity — Black or African American | 0 | 0 | 0 |
| Race/Ethnicity — Hispanic or Latino | 1 | 0 | 1 |
| Race/Ethnicity — Native Hawaiian or other Pacific Islander | 0 | 0 | 0 |
| Race/Ethnicity — White | 7 | 7 | 14 |
| Race/Ethnicity — Other | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment | Control | Total |
|---|---|---|---|
| United States | 8 | 7 | 15 |
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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