Clinical trial NCT06271746: Treatment of Fibromyalgia With the FibroNova Neuromodulation Device
Official title: A Prospective, Randomized, Double-blind, Sham-controlled Clinical Study Assessing the Safety and Efficacy of FibroNova for the Treatment of Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
Neuromodulation
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2024-02-22
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment. Randomized, double-blind, sham-controlled
Primary purpose: TREATMENT

Brief summary: Fibromyalgia (FM) is a chronic disorder that affects the musculoskeletal system, causing widespread pain, tenderness, and fatigue. It is estimated to affect 1-5% of the population. The primary symptom of fibromyalgia is widespread pain throughout the body, accompanied by tenderness and sensitivity to pressure.

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.

Detailed description: Background Fibromyalgia (FM) is a chronic disorder that affects the musculoskeletal system, causing widespread pain, tenderness, and fatigue. It is estimated to affect 1-5% of the population. The primary symptom of fibromyalgia is widespread pain throughout the body, accompanied by tenderness and sensitivity to pressure. Secondary symptoms include fatigue, sleep disturbances, cognitive difficulties, headaches, depression, and anxiety. The exact cause of fibromyalgia is unknown, but it is believed to involve a combination of neurobiological, genetic, and environmental factors.

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.

Eligibility criteria: Inclusion Criteria:

1. Patient age is 18-70.
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:

1. Change in prescribed medications for pain and/or fibromyalgia in the two months prior to enrolment.
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.

Primary outcomes:
measure: Mean reduction in pain level during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4)
timeFrame: 16 weeks
measure: Device safety (rate of adverse events and device related adverse events)
timeFrame: 28 weeks
Secondary outcomes:
measure: Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score
timeFrame: 16 weeks
measure: Mean change in FIQR functionality sub-scale score
timeFrame: 16 weeks
measure: Mean change in FIQR pain item score
timeFrame: 16 weeks
measure: Mean change in Brief Pain Inventory (BPI) score
timeFrame: 16 weeks
measure: Improvement in patient global impression according to PGIC score
timeFrame: 16 weeks
measure: Mean reduction in functional disability during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4)
timeFrame: 16 weeks
Other outcomes:
measure: Improvement in quality of life
timeFrame: 16 weeks
measure: Improvement in sleep quality
timeFrame: 16 weeks
measure: Mean change in level of depression
timeFrame: 16 weeks
measure: Mean change in level of anxiety
timeFrame: 16 weeks
measure: Mean change in level of cognitive impairment
timeFrame: 16 weeks
measure: Mean change in level of cognitive presenteeism
timeFrame: 16 weeks
measure: Mean reduction of at least 30% in pain level
timeFrame: 16 weeks
measure: Rate of treatment tolerability
timeFrame: 28 weeks
measure: User experience
timeFrame: 28 weeks
measure: Patient Global Impression- change (PGI-C
timeFrame: 28 weeks
measure: Patient Global Impression- change (PGI-C)- mid study:
timeFrame: 16 weeks
Locations:
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Springfield
country: United States
facility: ClinVest Headlands Research
state: Missouri
city: Virginia Beach
country: United States
facility: Gershon Pain Specialists
state: Virginia
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: University of Michigan
name: Daniel Clauw, MD
role: STUDY_CHAIR
References: