Treatment of Fibromyalgia With the FibroNova Neuromodulation Device
NCT ID: NCT06271746
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2024-03-04
2025-06-01
Brief Summary
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Pharmacological treatments include drugs such as antidepressants, anticonvulsants, and painkillers. Another treatment option for fibromyalgia is the use of devices such as Quell. Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy (CBT), biofeedback, and relaxation techniques.
Remote Electrical Neuromodulation (REN) is a non-pharmacological technology that induces subthreshold, non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation (CPM), to produce generalized pain relief in remote body areas. Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents, as well as migraine prevention.
The current study examines the safety and efficacy of REN technology, implemented via the FibroNova device for treating fibromyalgia pain and related symptoms.
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Detailed Description
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There is no cure for fibromyalgia, and only a minority of fibromyalgia patients continue taking medications for more than a short period due to either lack of efficacy, side effects, or both. Pharmacological treatments include drugs such as antidepressants, anticonvulsants, and painkillers, and operate by modulating pain signals in the brain and nervous system. Another treatment option for fibromyalgia is the use of devices, such as the Quell device by Neurometrix 3. Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy (CBT), biofeedback, and relaxation techniques 2.
Remote Electrical Neuromodulation (REN) is a non-pharmacological technology that induces subthreshold, non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation (CPM), to produce generalized pain relief in remote body areas. Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents, as well as migraine prevention.
The CPM system, which is deficient in patients with migraine, has been shown to be abnormal in fibromyalgia patients as well, suggesting that fibromyalgia patients could potentially benefit from activating the CPM via REN. The current study aims to examine the safety and efficacy of REN technology, implemented via the FibroNova device for the treatment of fibromyalgia pain and related symptoms.
The FibroNova device
The device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application. Treatments with FibroNova are self-administered by the user. The FibroNova device includes several main components:
* A pair of electrodes covered with hydrogel and a removeable protective film
* An electronic circuitry and a battery contained in a plastic case
* A software that includes firmware and a software application for mobile platforms
* An armband to improve the adhesiveness and enable a discreet treatment
The study design A prospective, randomized, double-blind, sham-controlled trial. The ratio between treatment and control groups will be 1:1, stratified by prior use of prescribed medications for FM (up to 2 vs. 3 or more). the following are considered as FM medications for the stratification: Dulloxetine, Pregabalin, Milnacipran, Amitriptyline.
The study will consist of two main phases and a voluntary open-label extension phase:
4-week baseline phase- in which participants will report their symptoms daily via an electronic app diary (with no intervention);
12-week intervention phase- in which eligible participants perform two treatments per day (using FibroNova/identical looking sham (placebo) device, according to randomization), and continue to report symptoms daily via the app.
12-week open-label extension phase (OLE)- upon completion of the intervention phase, eligible participants will be offered to participate in an additional voluntary 12-week period in which they will receive active treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment with active FibroNova device
Treatment of Fibromyalgia pain and symptoms with active FibroNova device. Participants will treat with an active device twice a day.
FibroNova (Active mode)
FibroNova neurostimulator of conditional pain modulation (CPM)
Treatment with Sham FibroNova device
Treatment of Fibromyalgia pain and symptoms with Sham FibroNova device. Participants will treat with a sham device twice a day.
FibroNova (Sham mode)
FibroNova neurostimulator with an electrical output not intended for neurostimulation
Interventions
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FibroNova (Active mode)
FibroNova neurostimulator of conditional pain modulation (CPM)
FibroNova (Sham mode)
FibroNova neurostimulator with an electrical output not intended for neurostimulation
Eligibility Criteria
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Inclusion Criteria
2. Meets ACR 2010 Diagnostic Criteria for FM.
3. Naïve to Nerivio and to FibroNova devices.
4. Possesses the basic cognitive and motor skills needed to operate his/her own smartphone.
5. Must be able and willing to comply with the protocol.
6. Must be able and willing to provide written informed consent.
Exclusion Criteria
2. Pregnant or lactating.
3. Has other significant comorbidities or pain problem(s) or undergoing specific therapies that in the opinion of the investigator may confound the study assessments.(e.g. active inflammatory joint disease, including spondyloarthropathy, or active malignancy, excluding Basal cell carcinoma).
4. Newly diagnosed with fibromyalgia (under six months).
5. Is currently implanted with an electrical and/or neurostimulation device (e.g., cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator bladder stimulator or Occipital nerve stimulator).
6. Known uncontrolled epilepsy.
7. Active substance use disorder that could interfere with study participation.
8. Use of opioids during the 2 months prior to enrolment.
9. Has undergone nerve block (occipital or other) during the 2 months prior to enrolment.
10. Patients with severe depression, and/or suicidality
11. Is participating in any other clinical study.
12. Use of a neuromodulation device specifically indicated for FM ( e.g.Quell ) currently or in the 2 months prior to enrolment.
18 Years
70 Years
ALL
No
Sponsors
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Theranica
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Clauw, MD
Role: STUDY_CHAIR
University of Michigan
Locations
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Clinical Research Professionals
Chesterfield, Missouri, United States
ClinVest Headlands Research
Springfield, Missouri, United States
Gershon Pain Specialists
Virginia Beach, Virginia, United States
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TCH101
Identifier Type: -
Identifier Source: org_study_id
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