FibromyalgiaPERRFECTNCT01958853
Prospective Evaluation of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) to Reduce Fibromyalgia Effects - Extension Study
A study testing RINCE in people with Fibromyalgia, run by Cerephex Corporation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- RINCE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- RINCE
- Keywords
- Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RINCEDevice
Also called RINCE therapy, RINCE therapy using the NeuroPoint device
The NeuroPoint device is used to deliver repeat applications of RINCE therapy
| Study group | Role | What they receive |
|---|---|---|
| 12-week RINCE | Experimental | RINCE - active RINCE therapy involving 24 total treatment applications from the NeuroPoint device Receives: Device: RINCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in patient 24-hour recall average pain intensity
Pain intensity evaluated on a 100-mm visual analog scale (VAS)
Measured: Assessed at 12 weeks
Secondary outcomes (4)
Patient self-reported Global Impression of Change
Measured: Assessed at 12 weeks
Change from baseline in Revised Fibromyalgia Impact Questionnaire
Measured: Assessed at 12 weeks
Change from baseline in patient 7-day recall average pain intensity
Measured: Assessed at 12 weeks
Change from baseline in Jenkins Sleep Questionnaire
Measured: Assessed at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerephex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald E Deering, PhD, Principal investigator, St. Joseph Mercy OaklandJeffrey B Hargrove, PhD, Principal investigator, Cerephex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958853
- Sponsor's protocol ID
- NPT-201E
- Acronym
- PERRFECT
- Status last verified
- Sep 2015
- First submitted
- 4 Oct 2013
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22233397Hargrove 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.
PubMed 22525670
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Trial for Patients With Fibromyalgia Who Complete Study NPT-201 (NCT01825954) and Who Experience Inadequate Pain Reduction
- ClinicalTrials.gov ID
- NCT01958853
- Acronym / sponsor ID
- PERRFECT / NPT-201E
- Conditions
- Fibromyalgia
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cerephex CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 12-week RINCE | Experimental | Device: RINCERINCE - active RINCE therapy involving 24 total treatment applications from the NeuroPoint device |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RINCEAlso: RINCE therapy, RINCE therapy using the NeuroPoint deviceThe NeuroPoint device is used to deliver repeat applications of RINCE therapy | Device | 12-week RINCE |
Primary outcome
Change from baseline in patient 24-hour recall average pain intensity
Time frame: Assessed at 12 weeks
Pain intensity evaluated on a 100-mm visual analog scale (VAS)
4 secondary outcomes
Patient self-reported Global Impression of Change
Time frame: Assessed at 12 weeks
Change from baseline in Revised Fibromyalgia Impact Questionnaire
Time frame: Assessed at 12 weeks
Change from baseline in patient 7-day recall average pain intensity
Time frame: Assessed at 12 weeks
Change from baseline in Jenkins Sleep Questionnaire
Time frame: Assessed at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Background: PubMed 22233397Hargrove 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.
- Background: PubMed 22525670Hargrove 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald E Deering, PhD principal investigator
St. Joseph Mercy Oakland
Jeffrey B Hargrove, PhD principal investigator
Cerephex Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RINCE in people with Fibromyalgia, run by Cerephex Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in patient 24-hour recall average pain intensity (time frame: Assessed at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958853, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.