FibromyalgiaPERRFECT-SJMONCT01825954
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - St. Joseph Mercy Oakland
A study testing RINCE in people with Fibromyalgia, run by Cerephex Corporation at 1 site 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 management of fibromyalgia. 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?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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 provide written informed consent and privacy authorization prior to participation in the study. Patient must have the ability to read and/or follow written and oral instructions, abide by the study restrictions, and agree to return for the required assessments.
- Patient is male or female, 22-65 years of age (inclusive) at the time of consent.
- Patient must have a confirmed diagnosis of fibromyalgia meeting the ACR 1990 classification criteria for fibromyalgia.
- Patients must have a 24-hour recall pain intensity score at both the screening and baseline visits between 40 and 90 inclusive on a 100 mm VAS scale.
- 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; history of suicide attempt within preceding 5 years or suicidal ideation within preceding 6 months; or any history of bipolar disorder, schizophrenia, schizoaffective or other psychotic 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 is currently using prohibited medications or treatments (see Prohibited Concomitant Therapy section of protocol) including FDA-approved fibromyalgia treatments, other centrally active analgesics, stimulants, anesthetic patches, CPAP and/or TENS therapy.
- Patient has an active diagnosis and is being treated for chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's disease, multiple sclerosis, hepatitis, polio, seizures, or cancer (other than basal or squamous cell skin cancer).
- Patient has any other chronic pain condition other than fibromyalgia that, in the Investigator's opinion, would interfere with the assessment of fibromyalgia (e.g., rheumatoid arthritis, post herpetic neuralgia, pain associated with diabetic neuropathy, severe pain due to degenerative joint disease, etc.)
- Patient has history of seizure disorder, dementia or epilepsy anytime during his or her life except pediatric febrile seizures.
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- Female patient who is pregnant, planning a pregnancy, or breastfeeding.
- Patient has any other disease or medical condition that, in the opinion of the investigator, would interfere with the evaluation of study device efficacy or safety, or would compromise the patient's ability to participate in or complete the study.
- Patient has a history of other cranial electrical stimulation device use, or electroconvulsive therapy.
- Patient has any metal implant, such as stents, aneurysm clips, shunts, pacemakers, defibrillators or neurostimulators. Long-bone implants are not excluded.
- Any anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol.
- Myocardial infarction during preceding 12 months, uncontrolled hypertension, active cardiac disease (American Heart Association Functional Class 2, 3 or 4 or Objective Class C or D), 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).
- Patients receiving systemic corticosteroids (> 5 mg prednisone or equivalent per day).
- Patients receiving regular or frequent opioids, opiates or narcotics.
- Pending or current litigation or disability claim (including Workman's Compensation). Patients currently receiving disability benefits will require medical monitor approval on a case-by-case basis.
- Patient has history of alcohol and/or drug abuse.
- Patient has participated in any investigational study within 30 days prior to Screening visit or is currently participating in another clinical trial.
- Patient has received any prior experimental treatment or therapy that, in the opinion of the medical monitor, would compromise the patient's ability to participate in the study.
- Patient is a staff member or relative of a staff member at either the investigative site or the Cerephex Corporation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blinded, Randomized, Sham-Controlled, Proof of Concept Study Exploring the Safety and Efficacy of RINCE Technology for the Treatment of Patients 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 management of fibromyalgia. Patients who meet the 1990 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, while the remaining two groups will receive different amounts of RINCE therapy. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. 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, Brain, Stimulation, Device
- 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 intervention uses the NeuroPoint device to deliver repeat applications of RINCE therapy stimulation. The sham uses the NeuroPoint device, but the RINCE therapy stimulation is not turned on.
| Study group | Role | What they receive |
|---|---|---|
| 12-week RINCE | Active comparator | RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device Receives: Device: RINCE |
| 8-week RINCE | Active comparator | RINCE - active RINCE therapy involving 16 total treatment applications from NeuroPoint device, followed by 8 sham applications from the NeuroPoint device 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 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
Pain intensity evaluated on a 100-mm visual analog scale (VAS)
Measured: Assessed at 12 weeks
Change from baseline in Jenkins Sleep Questionnaire
Sleep measures evaluated using a 100-mm visual analog scale (VAS)
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 posted8 Apr 2013 (estimated)
- Study startMar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerephex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825954
- Sponsor's protocol ID
- NPT-201
- Acronym
- PERRFECT-SJMO
- Status last verified
- Sep 2015
- First submitted
- 1 Apr 2013
- Last updated
- 17 Sep 2015
- Results posted
- 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
- A Double-Blinded, Randomized, Sham-Controlled, Proof of Concept Study Exploring the Safety and Efficacy of RINCE Technology for the Treatment of Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01825954
- Acronym / sponsor ID
- PERRFECT-SJMO / NPT-201
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Brain, Stimulation, Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cerephex CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Apr 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 study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the management of fibromyalgia. Patients who meet the 1990 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, while the remaining two groups will receive different amounts of RINCE therapy. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12-week RINCE | Active comparator | Device: RINCERINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device |
| 8-week RINCE | Active comparator | Device: RINCERINCE - active RINCE therapy involving 16 total treatment applications from NeuroPoint device, followed by 8 sham applications from the NeuroPoint device |
| Sham RINCE | Sham comparator | Device: RINCESham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must provide written informed consent and privacy authorization prior to participation in the study. Patient must have the ability to read and/or follow written and oral instructions, abide by the study restrictions, and agree to return for the required assessments.
- Patient is male or female, 22-65 years of age (inclusive) at the time of consent.
- Patient must have a confirmed diagnosis of fibromyalgia meeting the ACR 1990 classification criteria for fibromyalgia.
- Patients must have a 24-hour recall pain intensity score at both the screening and baseline visits between 40 and 90 inclusive on a 100 mm VAS scale.
- 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.
Key exclusion criteria (20 listed)
- Patient has a current significant psychological or psychiatric disorder (e.g., severe, unstable or poorly controlled depression, severe anxiety or obsessive-compulsive disorder; history of suicide attempt within preceding 5 years or suicidal ideation within preceding 6 months; or any history of bipolar disorder, schizophrenia, schizoaffective or other psychotic 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 is currently using prohibited medications or treatments (see Prohibited Concomitant Therapy section of protocol) including FDA-approved fibromyalgia treatments, other centrally active analgesics, stimulants, anesthetic patches, CPAP and/or TENS therapy.
- Patient has an active diagnosis and is being treated for chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's disease, multiple sclerosis, hepatitis, polio, seizures, or cancer (other than basal or squamous cell skin cancer).
- Patient has any other chronic pain condition other than fibromyalgia that, in the Investigator's opinion, would interfere with the assessment of fibromyalgia (e.g., rheumatoid arthritis, post herpetic neuralgia, pain associated with diabetic neuropathy, severe pain due to degenerative joint disease, etc.)
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 intervention uses the NeuroPoint device to deliver repeat applications of RINCE therapy stimulation. The sham uses the NeuroPoint device, but the RINCE therapy stimulation is not turned on. | Device | 12-week RINCE, 8-week RINCE, Sham 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.
The record lists no contact. Use the official record to reach the sponsor.
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 7 inclusion and 20 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. 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 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 NCT01825954, 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.