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| ID | Type | Description | Link |
|---|---|---|---|
| CDM00046436 | Other Identifier | BSC protocol number |
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The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precisionâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System for 6 months post-randomization |
|
| Control | Active Comparator | The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System for 6 months post-randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occipital nerve stimulator | Device | Electrical stimulation of the greater occipital nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | from Baseline to 6 months post-randomization |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Lipton, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Scientific Clinical Research Information Toll Free Number | Valencia | California | 91355 | United States | ||
28 subjects were consented in the study. 13 failed screening and 15 were randomized. Statistically relevant conclusions cannot be made from this small sample size.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve |
| FG001 | Control | The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention (6 Months) |
| |||||||||||||
| Open Label (24 Months) |
|
Randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
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. | All subjects who completed Baseline and 6 months post-randomization and had ≥70% of eDiary data. Data for 5 subjects was not calculated due to missing eDiary data. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions. | Posted | Median | Standard Deviation | days | from Baseline to 6 months post-randomization |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site irritation | General disorders |
Early termination leading to small numbers of subjects analyzed. Statistical analysis was not performed as the sample size was too small to draw any statistically relevant conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Sciences and Scientific Communication | Boston Scientific | Roshini.Jain@bsci.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| University of Illinois at Chicago (Implanting Physician) |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Diamond Headache Clinic (Headache Physician) | Chicago | Illinois | 60642 | United States |
| Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician) | Shreveport | Louisiana | 71105 | United States |
| Henry Ford Hospital (Headache Physician) | Detroit | Michigan | 48202 | United States |
| Henry Ford Medical Group (Implanting Physician) | West Bloomfield | Michigan | 48322 | United States |
| Mercy Pain Management -Surgery Center (Implanting Physician) | Springfield | Missouri | 65804 | United States |
| Clinvest Research, LLC (Headache Physician) | Springfield | Missouri | 65807 | United States |
| NYU Medical Center (Implanting Physician) | New York | New York | 10016 | United States |
| Montefiore Headache Center (Headache Physician) | The Bronx | New York | 10461 | United States |
| NOT COMPLETED |
|
The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System
Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Treatment | The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve |
| OG001 | Control | The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve |
|
|
| 0 |
| 8 |
| 4 |
| 8 |
| 3 |
| 8 |
| EG001 | Control | The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precisionâ„¢ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve | 0 | 7 | 1 | 7 | 3 | 7 |
| Status migrainosus | Nervous system disorders |
|
| Hemiplegic migraine | Nervous system disorders |
|
| Migraine without aura | Nervous system disorders |
|
| Adverse drug reaction | General disorders |
|
| Cellulitis | Infections and infestations |
|
| Wound dehiscence | Injury, poisoning and procedural complications |
|
| Nephrolithiasis | Renal and urinary disorders |
|
| Thrombosis | Vascular disorders |
|
| Device related infection | Infections and infestations |
|
| Migraine | Nervous system disorders |
|
| Carpal tunnel syndrome | Nervous system disorders |
|
| Impaired healing | General disorders |
|
| Diverticulitis | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Upper respiratory tract infection | Infections and infestations |
|
| Surgical skin tear | Injury, poisoning and procedural complications |
|
| Suture related complication | Injury, poisoning and procedural complications |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders |
|
| Renal failure acute | Renal and urinary disorders |
|
| Hypotension | Vascular disorders |
|
| Drug hypersensitivity | Immune system disorders |
|
| Body temperature increased | Investigations |
|
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| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |