Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202

NCT02613949 | Completed

• 1 other identifier: NPT-202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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 treatment of pain associated with fibromyalgia. Patients who meet the 2010 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. A second group will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A third group will receive active RINCE treatment at a higher than nominal signal amplitude level (treatment mode 2). The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' 24-hour recall average pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.

Conditions

Fibromyalgia

Keywords

fibromyalgia; pain; stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in patients' 24-hour recall average pain intensity

  The primary efficacy endpoint will be the contrast at 12 weeks versus Baseline in the (paired) mean weekly change in patients' self-reported daily (24-hour) recall average pain intensity using an 11-point (0-10) numerical rating scale.

  Assessed at 12 weeks

Secondary Outcomes (3)

• 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 patients' 7 day recall average pain intensity

  Assessed at 12 weeks

Study Arms (3)

12-week RINCE mode 1

ACTIVE COMPARATOR

RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device at treatment mode 1

Device: RINCE

12-week RINCE mode 2

ACTIVE COMPARATOR

RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device at treatment mode 2

Device: RINCE

Sham RINCE

SHAM COMPARATOR

Sham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device

Device: RINCE

Interventions

RINCE DEVICE

The NeuroPoint device is used to deliver repeat applications of RINCE therapy

Also known as: RINCE therapy, RINCE therapy delivered by the NeuroPoint device

12-week RINCE mode 1; 12-week RINCE mode 2; Sham RINCE

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male or female, 22 to 75 years of age, inclusive.
• Patient has a diagnosis of primary fibromyalgia as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia.
• At screening, the patient scores between 40 and 90 on a visual analog scale 24-hour recall pain scale, and between 4 and 9 inclusive on an 11 point numerical rating scale.
• If female, is either not of childbearing potential or is willing to utilize specified practices throughout the study to prevent becoming pregnant.
• Patient is willing and able to refrain or withdraw from the following therapies for the duration of the study: duloxetine, milnacipran, pregabalin, gabapentin, naltrexone, sodium oxybate, and opiates.
• Qualified patients with mild or moderate depression must be clinically stable, without risk of suicidal ideation or behavior, and the dose of allowed anti-depressants should have been stable for at least three months prior to the Baseline clinic visit.
• Patient is willing and able to comply with all protocol-specified requirements.
• Patient is capable of reading and understanding English and has provided written informed consent to participate.

You may not qualify if:

• The patient suffers from one or more of clinically significant psychiatric condition that could interfere with the patient's well-being or ability to comply with the protocol.
• Patient has a Beck Depression Inventory-II total score greater than 25 at either the Screening visit or Baseline clinic visit.
• The patient is at increased risk of suicide.
• Patient is unable, unwilling or not advised to refrain from or discontinue prohibited medications or treatments.
• Patient has a diagnosis of, or is being treated for, systemic lupus erythematosus, inflammatory arthritis, or other documented systemic autoimmune disorder, Parkinson's disease, multiple sclerosis, or cancer (other than basal or squamous cell skin cancer).
• Patient has any other chronic pain condition that, in the Investigator's or Sponsor's opinion, could interfere with the patient's assessment of his/her fibromyalgia status.
• Patient has a history of severe, refractory or uncontrolled migraine headaches, seizure disorder or clinically significant cognitive dysfunction.
• Patient is pregnant or planning to become pregnant within the next 6 months.
• Patient has a body mass index greater than 45 at the Screening visit.
• Patient has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the patient, interfere with the evaluation of the study device's efficacy or safety, or compromise the patient's ability to comply with/complete the study.
• Patient has a history of cranial electrical stimulation or transcutaneous magnetic stimulation within 2 years of screening, or electroconvulsive therapy within 5 years of screening; patient was enrolled in the Sponsor's previous NPT-301 study and received greater than 12 stimulation treatments.
• Patient has a metal implant at or above the level of the 7th cervical vertebra, a cardiac pacemaker or defibrillator, or vagus nerve stimulator.
• Any recent surgery or anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol.
• Myocardial infarction during the 12 months prior to screening, uncontrolled hypertension, active cardiac disease, clinically significant cardiac rhythm or conduction abnormality, or anticipation of bypass or other cardiac surgery within the next 12 months.
• Current systemic infection (e.g., HIV, hepatitis B or C; Lyme disease).

Sponsors & Collaborators

• Cerephex Corporation: lead

Study Sites (4)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Superior Research LLC

Sacramento, California, 95825, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Related Publications (2)

• 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.

  PMID: 22233397 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.

  PMID: 22525670 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• R. Michael Gendreau, MD PhD

  Cerephex Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: November 1, 2015
• Primary Completion: July 8, 2016
• Study Completion: July 29, 2016
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

US (4)