FibromyalgiaPERRFECT-UMNCT01914679
A Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - University of Michigan
A study testing RINCE in people with Fibromyalgia, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the mechanisms of 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 18 to 65 years, women only
- 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- Women only
- 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 female, 18-65 years of age (inclusive) at the time of consent.
- Patient must have a confirmed diagnosis of fibromyalgia meeting the ACR 1990 diagnostic 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 patient of childbearing potential must be willing to use an acceptable method of birth control for the duration of their study participation.
- 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.
- Participants undergoing fMRI and 1H-MRS must be predominantly right handed (i.e. the subject writes with their right hand).
Who cannot join
- The patient will not be eligible for enrollment if there is any history of, or in the opinion of the investigator, any of the following criteria are met:
- 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 total Hospital and Anxiety Depression score of 11-21 for either anxiety or depression, 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 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.)
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- Patient has history of seizure disorder, dementia or epilepsy anytime during his or her life except pediatric febrile seizures.
- 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, neurostimulators or other contraindications with fMRI and 1H-MRS. 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).
- 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.
- Body Mass Index (BMI) of greater than approximately 40 kg/m2.
- Claustrophobia or any other factor sufficiently significant that it is likely to prevent successful completion of fMRI and 1H-MRS procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Clinical Trial Evaluating Use of the NeuroPoint Medical Device as a Treatment for Fibromyalgia.
The purpose of this study is to evaluate the mechanisms of 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 20 patients will receive a combination of active and inactive (sham) therapy treatments over a 16-week period followed by a 4 week post-treatment evaluation. Patients will also undergo three (3) functional brain imaging scans while participating in the study: the first prior to the commencement of treatment, another mid-treatment; and the third at the completion of the treatment period.
The study's primary outcome measure will be the change from baseline in self-reported 24-hour average pain intensity. The study's hypothesis is that there will be a change in pain intensity as well brain functioning. We do not expect there to be a statistically significant improvement in pain intensity due to the small sample but do expect to see statistically significant changes in cortical function as measured by EEG and fMRI
- Conditions
- Fibromyalgia
- Being tested
- RINCE
- Keywords
- Fibromyalgia, Pain, Brain, Stimulation, Device, Treatment
- 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 delivered by NeuroPoint Device
The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
| Study group | Role | What they receive |
|---|---|---|
| Sham followed by device | Experimental | 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy followed by 12 weeks of RINCE therapy involving 24 total treatments Receives: Device: RINCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient 24-hour Recall Average Pain Intensity
The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable.
.
Measured: Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Sponsor terminated the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Intervention model
- Sequential
- Model description
- All participants went through a 4 week sham period, followed by a 12 week intervention with the device.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Cerephex Corporation
- Responsible party
- Principal investigator, Daniel Clauw, MD, University of Michigan
- Investigators
- Daniel J Clauw, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914679
- Sponsor's protocol ID
- NPT-201-UM
- Acronym
- PERRFECT-UM
- Status last verified
- Mar 2017
- First submitted
- 23 Jul 2013
- Last updated
- 19 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial Evaluating Use of the NeuroPoint Medical Device as a Treatment for Fibromyalgia.
- ClinicalTrials.gov ID
- NCT01914679
- Acronym / sponsor ID
- PERRFECT-UM / NPT-201-UM
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Brain, Stimulation, Device, Treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated the study
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Cerephex Corporation
- Study start
- Jul 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Posted 19 Apr 2017
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 evaluate the mechanisms of 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 20 patients will receive a combination of active and inactive (sham) therapy treatments over a 16-week period followed by a 4 week post-treatment evaluation. Patients will also undergo three (3) functional brain imaging scans while participating in the study: the first prior to the commencement of treatment, another mid-treatment; and the third at the completion of the treatment period.
The study's primary outcome measure will be the change from baseline in self-reported 24-hour average pain intensity. The study's hypothesis is that there will be a change in pain intensity as well brain functioning. We do not expect there to be a statistically significant improvement in pain intensity due to the small sample but do expect to see statistically significant changes in cortical function as measured by EEG and fMRI
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 1
- Model description
- All participants went through a 4 week sham period, followed by a 12 week intervention with the device.
| Arm | Type | Receives |
|---|---|---|
| Sham followed by device | Experimental | Device: RINCE4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy followed by 12 weeks of RINCE therapy involving 24 total treatments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 female, 18-65 years of age (inclusive) at the time of consent.
- Patient must have a confirmed diagnosis of fibromyalgia meeting the ACR 1990 diagnostic 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 patient of childbearing potential must be willing to use an acceptable method of birth control for the duration of their study participation.
Key exclusion criteria (22 listed)
- The patient will not be eligible for enrollment if there is any history of, or in the opinion of the investigator, any of the following criteria are met:
- 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 total Hospital and Anxiety Depression score of 11-21 for either anxiety or depression, 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 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).
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 delivered by NeuroPoint DeviceThe intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal. | Device | Sham followed by device |
Primary outcome
Change in Patient 24-hour Recall Average Pain Intensity
Time frame: Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)
The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable. .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel J Clauw, MD principal investigator
University of Michigan
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 University of Michigan 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 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: stopped early, as of the sponsor's last update on 19 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Patient 24-hour Recall Average Pain Intensity (time frame: Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2017.