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The purpose of this open label study is to provide up to 24 active treatments of noninvasive cortical electrostimulation therapy only to those fibromyalgia patients who experienced inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201 (NCT01825954). The therapy will be provided by the NeuroPoint device using the same protocol as that used in active treatment arms of NPT-201. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. The study will provide active treatment to those participants who received sham therapy in NPT-201, and will test whether or not additional therapy applications might further improve pain in those participants who previously received active therapy, but did not achieve adequate pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-week RINCE | Experimental | RINCE - active RINCE therapy involving 24 total treatment applications from the NeuroPoint device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RINCE | Device | The NeuroPoint device is used to deliver repeat applications of RINCE therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in patient 24-hour recall average pain intensity | Pain intensity evaluated on a 100-mm visual analog scale (VAS) | Assessed at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-reported Global Impression of Change | Assessed at 12 weeks | |
| Change from baseline in Revised Fibromyalgia Impact Questionnaire | Assessed at 12 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Beck Depression Inventory (BDI-II) | Assessed at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald E Deering, PhD | St. Joseph Mercy Oakland | Principal Investigator |
| Jeffrey B Hargrove, PhD | Cerephex Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22233397 | Background | Hargrove JB, Bennett RM, Simons DG, Smith SJ, Nagpal S, Deering DE. A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients. Pain Med. 2012 Jan;13(1):115-24. doi: 10.1111/j.1526-4637.2011.01292.x. | |
| 22525670 | Background | Hargrove JB, Bennett RM, Clauw DJ. Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Arch Phys Med Rehabil. 2012 Oct;93(10):1868-71. doi: 10.1016/j.apmr.2012.04.006. Epub 2012 Apr 21. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Change from baseline in patient 7-day recall average pain intensity |
| Assessed at 12 weeks |
| Change from baseline in Jenkins Sleep Questionnaire | Assessed at 12 weeks |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |