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

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: RINCE

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Pontiac, Michigan, United States, 48341
      • St. Joseph Mercy Oakland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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	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

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Beck Depression Inventory (BDI-II)	Assessed at 12 weeks

Collaborators and Investigators

• Sponsor: Cerephex Corporation
• Investigators: Principal Investigator: Donald E Deering, PhD, St. Joseph Mercy Oakland; Principal Investigator: Jeffrey B Hargrove, PhD, Cerephex Corporation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 4, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Estimate): September 17, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: NPT-201E