Prospective Evaluation of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) to Reduce Fibromyalgia Effects - Extension Study

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Extension Trial for Patients With Fibromyalgia Who Complete Study NPT-201 (NCT01825954) and Who Experience Inadequate Pain Reduction

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: RINCE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have successfully completed study NPT-201 and had an inadequate pain response, defined as <50% reduction in pain from baseline during participation in NPT-201. Patient must provide written informed consent and privacy authorization prior to participation in the study. Female patients of childbearing potential must be willing to use an acceptable method of birth control for the duration of their study participation. Acceptable birth control includes a vasectomized partner, contraceptives (oral, parenteral, or transdermal), intrauterine device, or double barrier method including condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream. Patients considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or greater than one year post-menopausal, defined as a complete cessation of menstruation for at least one year. Patients must be willing to refrain from all excluded therapies for the duration of the study. In the opinion of the Investigator, the patient is willing and able to comply with all protocol-specified requirements. Exclusion Criteria: Patient has a current significant psychological or psychiatric disorder (e.g., severe, unstable or poorly controlled depression, severe anxiety or obsessive-compulsive disorder. Patient has a score of 2 or 3 on item 9 of the BDI, or, based on the investigator's judgment, the patient is at risk of suicidal ideation or behavior. Patient has resumed treatment with duloxetine, milnacipran, pregabalin, gabapentin, sodium oxybate or prohibited narcotics. Female patient who is pregnant, planning a pregnancy, or breastfeeding. Any anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol. The occurrence of a major protocol violation during the lead-in study indicating a lack of compliance or other significant concern that precludes the patient's ongoing participation.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12-week RINCE<br>RINCE - active RINCE therapy involving 24 total treatment applications from the NeuroPoint device | Device: RINCE<br>* The NeuroPoint device is used to deliver repeat applications of RINCE therapy<br>* Other names: RINCE therapy using the NeuroPoint device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain