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The study is designed as a prospective, randomized, double-blind, single center study with a 6 month duration post permanent system implantation. Forty patients will be implanted.
During trial stimulation, patients will be randomized into one of two study arms for two weeks. Crossover will occur at the 2 week study visit to the opposite group. After completion of these two arms, every patient will subsequently complete participation in the third study arm.
After completion of the third arm, patients will be evaluated to determine if they are a positive responder responder. If so, the patient will have the option of obtaining the permanent implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprathreshold Stimulation | Active Comparator | Patients will be stimulated at supra-sensory threshold levels for two weeks using occipital stimulation |
|
| minimal stimulation | Sham Comparator | Patients will be stimulated at minimal stimulation for two weeks using occipital stimulation |
|
| Subthreshold Stimulation | Active Comparator | Patients will be stimulated at sub-sensory threshold stimulation for two weeks using occipital stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occipital Stimulation | Device | Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) | The Fibromyalgia Impact Questionnaire (FIQ) is a self administered scale that was developed to measure fibromyalgia patient status, progress and outcomes. It measures the components of health that are most affected by fibromyalgia. The maximum score is 100 and a higher score indicates a greater impact of the syndrome on the person. The change in the Fibromyalgia Impact Questionnaire (FIQ) will be analyzed and reported. | End of 6 week stimulation trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roni Diaz | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Antwerp | Belgium |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| D009422 |
| Nervous System Diseases |