Treatment for Migraines With an Implantable Device
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| ClinicalTrials.gov Identifier: NCT00286078 |
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Recruitment Status :
Completed
First Posted : February 3, 2006
Results First Posted : August 9, 2016
Last Update Posted : July 30, 2019
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Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Migraine |
| Intervention |
Device: Precision |
| Enrollment | 179 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 179 subjects signed consent, 39 subjects screen failed, and 140 eligible subjects were randomized (1 subject was later excluded). |
| Arm/Group Title | Treatment | Control |
|---|---|---|
 Arm/Group Description |
Active occipital nerve stimulation (stimulation on). Precision: Implantable neurostimulator |
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on. |
| Period Title: Overall Study | ||
| Started | 72 | 68 |
| 12 Weeks | 63 | 62 |
| Completed | 40 | 34 |
| Not Completed | 32 | 34 |
Baseline Characteristics
| Arm/Group Title | Treatment | Control | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Stimulation on Precision: Implantable neurostimulator |
Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on. Precision: Implantable neurostimulator |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 71 | 68 | 139 | |
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Baseline Analysis Population Description |
1 subject excluded from analysis because HIPAA authorization was not obtained; randomized to active group, received percutaneous trial only
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 71 participants | 68 participants | 139 participants | |
| 41.5 (11.2) | 43.8 (11.9) | 42.6 (11.6) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 71 participants | 68 participants | 139 participants | |
| Female |
60 84.5%
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57 83.8%
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117 84.2%
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| Male |
11 15.5%
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11 16.2%
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22 15.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 71 participants | 68 participants | 139 participants |
| 71 | 68 | 139 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Clinical Research Information |
| Organization: | Boston Scientific |
| Phone: | 855-213-9890 |
| EMail: | BSNClinicalTrials@bsci.com |
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00286078 |
| Other Study ID Numbers: |
EI0105 |
| First Submitted: | February 1, 2006 |
| First Posted: | February 3, 2006 |
| Results First Submitted: | April 6, 2016 |
| Results First Posted: | August 9, 2016 |
| Last Update Posted: | July 30, 2019 |