Clinical trial NCT01958853: Prospective Evaluation of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) to Reduce Fibromyalgia Effects - Extension Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Pain
Lead sponsor: Cerephex Corporation
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 23
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in patient 24-hour recall average pain intensity
timeFrame: Assessed at 12 weeks
Secondary outcomes:
measure: Patient self-reported Global Impression of Change
timeFrame: Assessed at 12 weeks
measure: Change from baseline in Revised Fibromyalgia Impact Questionnaire
timeFrame: Assessed at 12 weeks
measure: Change from baseline in patient 7-day recall average pain intensity
timeFrame: Assessed at 12 weeks
measure: Change from baseline in Jenkins Sleep Questionnaire
timeFrame: Assessed at 12 weeks
Other outcomes:
measure: Change from baseline in Beck Depression Inventory (BDI-II)
timeFrame: Assessed at 12 weeks
Locations:
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland
state: Michigan
Study officials:
affiliation: St. Joseph Mercy Oakland
name: Donald E Deering, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cerephex Corporation
name: Jeffrey B Hargrove, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.