FibromyalgiaPERRFECT-202NCT02613949
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202
A study testing RINCE in people with Fibromyalgia, run by Cerephex Corporation at 4 sites in United States.
Trial summary
The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- RINCE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2015to 29 Jul 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or female, 22 to 75 years of age, inclusive.
- Patient has a diagnosis of primary fibromyalgia as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia.
- At screening, the patient scores between 40 and 90 on a visual analog scale 24-hour recall pain scale, and between 4 and 9 inclusive on an 11 point numerical rating scale.
- If female, is either not of childbearing potential or is willing to utilize specified practices throughout the study to prevent becoming pregnant.
- Patient is willing and able to refrain or withdraw from the following therapies for the duration of the study: duloxetine, milnacipran, pregabalin, gabapentin, naltrexone, sodium oxybate, and opiates.
- Qualified patients with mild or moderate depression must be clinically stable, without risk of suicidal ideation or behavior, and the dose of allowed anti-depressants should have been stable for at least three months prior to the Baseline clinic visit.
- Patient is willing and able to comply with all protocol-specified requirements.
- Patient is capable of reading and understanding English and has provided written informed consent to participate.
Who cannot join
- The patient suffers from one or more of clinically significant psychiatric condition that could interfere with the patient's well-being or ability to comply with the protocol.
- Patient has a Beck Depression Inventory-II total score greater than 25 at either the Screening visit or Baseline clinic visit.
- The patient is at increased risk of suicide.
- Patient is unable, unwilling or not advised to refrain from or discontinue prohibited medications or treatments.
- Patient has a diagnosis of, or is being treated for, systemic lupus erythematosus, inflammatory arthritis, or other documented systemic autoimmune disorder, Parkinson's disease, multiple sclerosis, or cancer (other than basal or squamous cell skin cancer).
- Patient has any other chronic pain condition that, in the Investigator's or Sponsor's opinion, could interfere with the patient's assessment of his/her fibromyalgia status.
Show all 22Show fewer
- Patient has a history of severe, refractory or uncontrolled migraine headaches, seizure disorder or clinically significant cognitive dysfunction.
- Patient is pregnant or planning to become pregnant within the next 6 months.
- Patient has a body mass index greater than 45 at the Screening visit.
- Patient meets any of the study's exclusionary laboratory criteria.
- Patient has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the patient, interfere with the evaluation of the study device's efficacy or safety, or compromise the patient's ability to comply with/complete the study.
- Patient has a history of cranial electrical stimulation or transcutaneous magnetic stimulation within 2 years of screening, or electroconvulsive therapy within 5 years of screening; patient was enrolled in the Sponsor's previous NPT-301 study and received greater than 12 stimulation treatments.
- Patient has a metal implant at or above the level of the 7th cervical vertebra, a cardiac pacemaker or defibrillator, or vagus nerve stimulator.
- Any recent surgery or anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol.
- Myocardial infarction during the 12 months prior to screening, uncontrolled hypertension, active cardiac disease, clinically significant cardiac rhythm or conduction abnormality, or anticipation of bypass or other cardiac surgery within the next 12 months.
- Current systemic infection (e.g., HIV, hepatitis B or C; Lyme disease).
- Patient is receiving systemic corticosteroids greater than 5 mg prednisone or equivalent per day.
- Patient is using opiates on a regular or frequent basis.
- Pending or current litigation or disability claim (including Workman's Compensation).
- History of significant alcohol and/or drug abuse or dependency within preceding 5 years, or a positive result on the screening (or subsequent) drug screen indicating use of an illicit substance.
- Patient has participated in an investigational study of a therapeutic treatment within 90 days prior to Screening visit or is currently participating in another clinical trial.
- Patient is a staff member or relative of a staff member at either the investigative site or the sponsor.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Chicago Research Center
Chicago, Illinois, 60634
Superior Research LLC
Sacramento, California, 95825
Upstate Clinical Research Associates
Williamsville, New York, 14221
About this study
Official title: A Double-Blinded, Randomized, Sham-Controlled, Study of the Revised NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia
The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Patients who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 45 fibromyalgia patients will be randomized into one of three study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all. A second group will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A third group will receive active RINCE treatment at a higher than nominal signal amplitude level (treatment mode 2). The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' 24-hour recall average pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.
- Conditions
- Fibromyalgia
- Being tested
- RINCE
- Keywords
- fibromyalgia, pain, stimulation
- 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 delivered by the NeuroPoint device
The NeuroPoint device is used to deliver repeat applications of RINCE therapy
| Study group | Role | What they receive |
|---|---|---|
| 12-week RINCE mode 1 | Active comparator | RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device at treatment mode 1 Receives: Device: RINCE |
| 12-week RINCE mode 2 | Active comparator | RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device at treatment mode 2 Receives: Device: RINCE |
| Sham RINCE | Sham comparator | Sham RINCE - sham RINCE therapy involving 24 total sham applications from 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 patients' 24-hour recall average pain intensity
The primary efficacy endpoint will be the contrast at 12 weeks versus Baseline in the (paired) mean weekly change in patients' self-reported daily (24-hour) recall average pain intensity using an 11-point (0-10) numerical rating scale.
Measured: Assessed at 12 weeks
Secondary outcomes (3)
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 patients' 7 day recall average pain intensity
Average pain intensity evaluated using an 11-point (0-10) numerical rating scale.
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 posted25 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion8 Jul 2016
- Study completion29 Jul 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerephex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. Michael Gendreau, MD PhD, Study director, Cerephex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613949
- Sponsor's protocol ID
- NPT-202
- Acronym
- PERRFECT-202
- Status last verified
- Jan 2018
- First submitted
- 23 Nov 2015
- Last updated
- 26 Jan 2018
- 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 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized, Sham-Controlled, Study of the Revised NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia
- ClinicalTrials.gov ID
- NCT02613949
- Acronym / sponsor ID
- PERRFECT-202 / NPT-202
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, pain, stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cerephex CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 25 Nov 2015 (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 study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Patients who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 45 fibromyalgia patients will be randomized into one of three study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all. A second group will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A third group will receive active RINCE treatment at a higher than nominal signal amplitude level (treatment mode 2). The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' 24-hour recall average pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12-week RINCE mode 1 | Active comparator | Device: RINCERINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device at treatment mode 1 |
| 12-week RINCE mode 2 | Active comparator | Device: RINCERINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device at treatment mode 2 |
| Sham RINCE | Sham comparator | Device: RINCESham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is male or female, 22 to 75 years of age, inclusive.
- Patient has a diagnosis of primary fibromyalgia as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia.
- At screening, the patient scores between 40 and 90 on a visual analog scale 24-hour recall pain scale, and between 4 and 9 inclusive on an 11 point numerical rating scale.
- If female, is either not of childbearing potential or is willing to utilize specified practices throughout the study to prevent becoming pregnant.
- Patient is willing and able to refrain or withdraw from the following therapies for the duration of the study: duloxetine, milnacipran, pregabalin, gabapentin, naltrexone, sodium oxybate, and opiates.
Key exclusion criteria (22 listed)
- The patient suffers from one or more of clinically significant psychiatric condition that could interfere with the patient's well-being or ability to comply with the protocol.
- Patient has a Beck Depression Inventory-II total score greater than 25 at either the Screening visit or Baseline clinic visit.
- The patient is at increased risk of suicide.
- Patient is unable, unwilling or not advised to refrain from or discontinue prohibited medications or treatments.
- Patient has a diagnosis of, or is being treated for, systemic lupus erythematosus, inflammatory arthritis, or other documented systemic autoimmune disorder, Parkinson's disease, multiple sclerosis, or cancer (other than basal or squamous cell skin cancer).
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 delivered by the NeuroPoint deviceThe NeuroPoint device is used to deliver repeat applications of RINCE therapy | Device | 12-week RINCE mode 1, 12-week RINCE mode 2, Sham RINCE |
Primary outcome
Change from baseline in patients' 24-hour recall average pain intensity
Time frame: Assessed at 12 weeks
The primary efficacy endpoint will be the contrast at 12 weeks versus Baseline in the (paired) mean weekly change in patients' self-reported daily (24-hour) recall average pain intensity using an 11-point (0-10) numerical rating scale.
3 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 patients' 7 day recall average pain intensity
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 26 Jan 2018.
- 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.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
R. Michael Gendreau, MD PhD study director
Cerephex Corporation
4 sites 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 4 sites 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 8 inclusion and 22 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 patients' 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 NCT02613949, 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 26 Jan 2018.