Migraine Disorders
Conditions
Keywords
headache, pain, chronic
Brief summary
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.
Detailed description
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).
Interventions
Electrical stimulation of the greater occipital nerve
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Moderate-to-severe Headache Days Per Month | from Baseline to 6 months post-randomization | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System
Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve | 8 |
| Control The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System
Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment United States | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 3 / 8 | 3 / 7 |
| serious Total, serious adverse events | 4 / 8 | 1 / 7 |
Outcome results
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: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in the Number of Moderate-to-severe Headache Days Per Month | -5.2 days | Standard Deviation 7.3 |
| Control | Change in the Number of Moderate-to-severe Headache Days Per Month | 0 days | Standard Deviation 10.8 |