Back to results

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

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RINCE

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Pain

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

St. Joseph Mercy Oakland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

12-week RINCE

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Patient self-reported Global Impression of Change

Change from baseline in Revised Fibromyalgia Impact Questionnaire

Change from baseline in patient 7-day recall average pain intensity

Change from baseline in Jenkins Sleep Questionnaire

Full Information

NCT ID

NCT01958853

First Posted

October 4, 2013

Last Updated

September 2, 2015

Sponsor

Cerephex Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01958853

Brief Title

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

Acronym

PERRFECT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cerephex Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

12-week RINCE

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

RINCE

Other Intervention Name(s)

RINCE therapy, RINCE therapy using the NeuroPoint device

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Assessed at 12 weeks

Secondary Outcome Measure Information:

Title

Patient self-reported Global Impression of Change

Time Frame

Assessed at 12 weeks

Title

Change from baseline in Revised Fibromyalgia Impact Questionnaire

Time Frame

Assessed at 12 weeks

Title

Change from baseline in patient 7-day recall average pain intensity

Time Frame

Assessed at 12 weeks

Title

Change from baseline in Jenkins Sleep Questionnaire

Time Frame

Assessed at 12 weeks

Other Pre-specified Outcome Measures:

Title

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

Time Frame

Assessed at 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald E Deering, PhD

Organizational Affiliation

St. Joseph Mercy Oakland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey B Hargrove, PhD

Organizational Affiliation

Cerephex Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph Mercy Oakland

City

Pontiac

State/Province

Michigan

ZIP/Postal Code

48341

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22233397

Citation

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.

Results Reference

background

PubMed Identifier

22525670

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs