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

NCT ID: NCT01958853

Last Updated: 2015-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

12-week RINCE

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

Group Type: EXPERIMENTAL

RINCE

Intervention Type: DEVICE

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

Interventions

RINCE

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

Intervention Type: DEVICE

Other Intervention Names

RINCE therapy; RINCE therapy using the NeuroPoint device

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerephex Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald E Deering, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph Mercy Oakland

Jeffrey B Hargrove, PhD

Role: PRINCIPAL_INVESTIGATOR

Cerephex Corporation

Locations

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22233397 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22525670 (View on PubMed)

Other Identifiers

NPT-201E

Identifier Type: -

Identifier Source: org_study_id