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

NCT01958853 | Completed

• 1 other identifier: NPT-201E
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Outcomes (1)

• Change from baseline in Beck Depression Inventory (BDI-II)

  Assessed at 12 weeks

Study Arms (1)

12-week RINCE

EXPERIMENTAL

RINCE - active RINCE therapy involving 24 total treatment applications from the 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 using the NeuroPoint device

12-week RINCE

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerephex Corporation: lead

Study Sites (1)

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341, 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

• Donald E Deering, PhD

  St. Joseph Mercy Oakland

  PRINCIPAL INVESTIGATOR

• Jeffrey B Hargrove, PhD

  Cerephex Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 9, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

US (1)