A Double-Blinded, Randomized, Sham-Controlled, Proof of Concept Study Exploring the Safety and Efficacy of RINCE Technology for the Treatment of Patients With Fibromyalgia

Cerephex Corporation1 site in 1 country46 target enrollmentMarch 2013

ConditionsFibromyalgia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Cerephex Corporation
Enrollment: 46
Locations: 1
Primary Endpoint: Change from baseline in patient 24-hour recall average pain intensity
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the management of fibromyalgia. Patients who meet the 1990 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 45 fibromyalgia patients will be randomized into one of three study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all, while the remaining two groups will receive different amounts of RINCE therapy. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

May 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cerephex Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient must provide written informed consent and privacy authorization prior to participation in the study. Patient must have the ability to read and/or follow written and oral instructions, abide by the study restrictions, and agree to return for the required assessments.
•Patient is male or female, 22-65 years of age (inclusive) at the time of consent.
•Patient must have a confirmed diagnosis of fibromyalgia meeting the ACR 1990 classification criteria for fibromyalgia.
•Patients must have a 24-hour recall pain intensity score at both the screening and baseline visits between 40 and 90 inclusive on a 100 mm VAS scale.
•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; history of suicide attempt within preceding 5 years or suicidal ideation within preceding 6 months; or any history of bipolar disorder, schizophrenia, schizoaffective or other psychotic 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 is currently using prohibited medications or treatments (see Prohibited Concomitant Therapy section of protocol) including FDA-approved fibromyalgia treatments, other centrally active analgesics, stimulants, anesthetic patches, CPAP and/or TENS therapy.
•Patient has an active diagnosis and is being treated for chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's disease, multiple sclerosis, hepatitis, polio, seizures, or cancer (other than basal or squamous cell skin cancer).
•Patient has any other chronic pain condition other than fibromyalgia that, in the Investigator's opinion, would interfere with the assessment of fibromyalgia (e.g., rheumatoid arthritis, post herpetic neuralgia, pain associated with diabetic neuropathy, severe pain due to degenerative joint disease, etc.)
•Patient has history of seizure disorder, dementia or epilepsy anytime during his or her life except pediatric febrile seizures.
•Female patient who is pregnant, planning a pregnancy, or breastfeeding.
•Patient has any other disease or medical condition that, in the opinion of the investigator, would interfere with the evaluation of study device efficacy or safety, or would compromise the patient's ability to participate in or complete the study.
•Patient has a history of other cranial electrical stimulation device use, or electroconvulsive therapy.
•Patient has any metal implant, such as stents, aneurysm clips, shunts, pacemakers, defibrillators or neurostimulators. Long-bone implants are not excluded.

Outcomes

Primary Outcomes

Change from baseline in patient 24-hour recall average pain intensity

Time Frame: Assessed at 12 weeks

Pain intensity evaluated on a 100-mm visual analog scale (VAS)

Secondary Outcomes

Change from baseline in Jenkins Sleep Questionnaire(Assessed at 12 weeks)
Change from baseline in Revised Fibromyalgia Impact Questionnaire(Assessed at 12 weeks)
Patient self-reported Global Impression of Change(Assessed at 12 weeks)
Change from baseline in patient 7-day recall average pain intensity(Assessed at 12 weeks)