Neuromodulation Device for Fibromyalgia

Recruiting at 3 trial locations

Overseen By Steven Gershon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Theranica

Must not be taking: Opioids

Disqualifiers: Pregnancy, Severe depression, Epilepsy, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial is testing a new device called the FibroNova Neuromodulation Device to determine if it can safely and effectively relieve pain and other symptoms in people with fibromyalgia, a condition that causes widespread pain and fatigue. The study will compare the actual device's effectiveness against a sham (inactive) version, with participants using the device twice a day. The trial seeks individuals who have had fibromyalgia for more than six months and have not used similar neuromodulation devices before. Participants should also be comfortable using a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve fibromyalgia treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have changed your prescribed medications for pain or fibromyalgia in the two months before joining the study.

What prior data suggests that the FibroNova Neuromodulation Device is safe for treating fibromyalgia?

Research has shown that Remote Electrical Neuromodulation (REN) is safe for treating migraines in both adults and teens. The FibroNova device uses this same technology for fibromyalgia. REN sends gentle signals to manage pain without causing discomfort. Studies on migraines have found it to be well-tolerated, with no major side effects reported.

Although the FibroNova device is new for fibromyalgia, the safety data from migraine treatments is encouraging. These studies suggest that this type of treatment is generally safe and can provide relief without serious risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FibroNova Neuromodulation Device because it offers a new way to manage fibromyalgia symptoms. Unlike traditional treatments like pain relievers or antidepressants, which primarily focus on masking symptoms, this device targets the nervous system directly to modulate pain signals. By using neuromodulation, FibroNova could potentially provide relief without the side effects associated with medications. This innovative approach has the potential to improve the quality of life for fibromyalgia patients by addressing the root of their pain more effectively.

What evidence suggests that the FibroNova Neuromodulation Device is effective for fibromyalgia?

Research has shown that Remote Electrical Neuromodulation (REN) technology, such as the FibroNova device, can help manage fibromyalgia pain. REN sends gentle signals to the nerves, activating the body's natural pain-relief system. In this trial, participants will receive treatment with either an active FibroNova device or a sham device. Studies on similar treatments have demonstrated significant improvements in pain and quality of life for people with fibromyalgia. This method has also proven safe and effective for treating migraines, suggesting it may benefit those with fibromyalgia as well. Early evidence is promising, indicating potential for meaningful pain relief without medication. ^{1 2 3 5 6}

Who Is on the Research Team?

Daniel Clauw, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with fibromyalgia or myofascial pain syndrome, experiencing widespread body pain, tenderness, and fatigue. Participants should be seeking non-pharmacological treatment options.

Inclusion Criteria

Meets ACR 2010 Diagnostic Criteria for FM

Naïve to Nerivio and to FibroNova devices

Must be able and willing to provide written informed consent

Exclusion Criteria

Active substance use disorder that could interfere with study participation

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)

Pregnant or lactating

Timeline for a Trial Participant

Baseline

Participants report their symptoms daily via an electronic app diary with no intervention

4 weeks

Intervention

Eligible participants perform two treatments per day using the FibroNova or sham device and continue to report symptoms daily via the app

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Eligible participants are offered an additional voluntary 12-week period of active treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FibroNova Neuromodulation Device

Trial Overview The study tests the FibroNova device's safety and effectiveness in treating fibromyalgia symptoms. It uses Remote Electrical Neuromodulation to potentially ease pain by activating the body's own pain management system.

How Is the Trial Designed?

Group I: Treatment with active FibroNova device Active Control 1 Intervention

Treatment of Fibromyalgia pain and symptoms with active FibroNova device. Participants will treat with an active device twice a day.

Group II: Treatment with Sham FibroNova device Placebo Group 1 Intervention

Treatment of Fibromyalgia pain and symptoms with Sham FibroNova device. Participants will treat with a sham device twice a day.

FibroNova Neuromodulation Device is already approved in United States for the following indications:

Approved in United States as FibroNova Neuromodulation Device for:

• Fibromyalgia pain and related symptoms

Who Is Running the Clinical Trial?

Theranica

Lead Sponsor

Trials

21

Recruited

41,700+

Published Research Related to This Trial

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

Fibromyalgia affects about 2% of people in the U.S., primarily women, and is characterized by chronic pain, fatigue, and cognitive issues, making accurate diagnosis crucial using tools like the Fibromyalgia Rapid Screening Tool.

A multidisciplinary treatment approach, including patient education, exercise, cognitive behavior therapy, and medications like duloxetine and pregabalin, is most effective, while nonsteroidal anti-inflammatory drugs and opioids are not beneficial for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibromyalgia: Diagnosis and Management. Winslow, BT., Vandal, C., Dang, L.[2023]

Non-invasive neuro-adaptive electrostimulation (NAE) therapy significantly reduced pain in women with fibromyalgia compared to a sham treatment, showing a 3-point improvement on the Visual Analog Scale immediately after the intervention and at 3 months follow-up.

While NAE therapy improved pain and quality of life after 4 weeks, these benefits did not persist at the 3-month follow-up, indicating the need for further research to explore long-term efficacy in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of neuro-adaptive electrostimulation therapy on pain and disability in fibromyalgia: A prospective, randomized, double-blind study. Udina-Cortés, C., Fernández-Carnero, J., Romano, AA., et al.[2021]

In a study involving 37 patients with fibromyalgia syndrome, treatments using Radio Electric Asymmetric Conveyer (REAC) technology significantly improved motor responses and quality of life, including reductions in pain and functional dysmetria after 18 sessions of Neuro Psycho Physical Optimization.

The results suggest that REAC treatments can effectively enhance the neurobiological balance in fibromyalgia patients, potentially reducing the need for analgesic medications and improving their ability to perform daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REAC Neurobiological Modulation as a Precision Medicine Treatment for Fibromyalgia. Silva, A., Barcessat, AR., Gonçalves, R., et al.[2023]

In a randomized placebo-controlled trial involving 90 female patients with fibromyalgia, photobiomodulation therapy combined with a static magnetic field (PBMT-sMF) significantly reduced pain levels and the number of tender points compared to a placebo, both at the end of treatment and during follow-up.

No adverse events were reported, indicating that PBMT-sMF is a safe and effective treatment option that could be considered as an important addition to existing fibromyalgia treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy combined with static magnetic field is better than placebo in patients with fibromyalgia: a randomized placebo-controlled trial. Ribeiro, NF., Leal-Junior, ECP., Johnson, DS., et al.[2023]

A follow-up study of 69 fibromyalgia patients, conducted 45 months after a randomized controlled trial, showed significant long-term improvements in symptoms, with Fibromyalgia Impact Questionnaire scores decreasing from 52.6 at baseline to 31.8 at follow-up (P<.001).

Patients reported lasting benefits from noninvasive cortical stimulation therapy, including reduced medication use and fewer doctor visits for fibromyalgia, indicating the treatment's sustained efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Hargrove, JB., Bennett, RM., Clauw, DJ.[2015]

A novel drug-free solution using a wristband that emits millimeter waves, combined with a therapeutic coaching program, is being tested on 170 fibromyalgia patients to improve their quality of life over 3 months.

The study aims to evaluate the effectiveness of this approach in reducing pain, anxiety, and sleep disturbances, potentially offering a non-medicinal treatment option for fibromyalgia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial. Chipon, E., Bosson, JL., Minier, L., et al.[2022]

Neuroprosthetic devices like deep brain stimulation (DBS) show promise in treating neurological disorders, but current funding and regulatory structures hinder investigator-initiated research in this area.

The authors highlight five key areas for reform to improve the landscape for device-based clinical trials, emphasizing the need for better funding mechanisms and regulatory pathways to encourage innovation and ultimately benefit patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to investigator-initiated deep brain stimulation and device research. Kelly, ML., Malone, D., Okun, MS., et al.[2023]

The newly developed silicone-based nerve cuff lead with a hydrogel microfluidic conduit allows for safe and effective stimulation of nerves, providing a flexible interface that reduces biological damage compared to traditional metal electrodes.

This device enables the delivery of direct current (DC) for reversible nerve block in an in vivo rat model, demonstrating comparable performance to metal electrodes while being easier to manufacture with consumer-grade tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Hydrogel-Based Microfluidic Nerve Cuff for Neuromodulation of Peripheral Nerves. Thakur, R., Aplin, FP., Fridman, GY.[2022]

In a study of 119 participants with fibromyalgia, the use of a transcutaneous electrical nerve stimulation (TENS) device did not show significant differences in symptom relief compared to a sham treatment after three months, indicating limited overall efficacy.

However, individuals with higher hypersensitivity experienced more improvement with the active TENS treatment, suggesting that TENS may be more beneficial for certain subgroups of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Pain Sensitivity Predicts Efficacy of a Wearable Transcutaneous Electrical Nerve Stimulation Device for Persons With Fibromyalgia: A Randomized Double-Blind Sham-Controlled Trial. Jamison, RN., Curran, S., Wan, L., et al.[2022]

A study revealed that healthcare providers had a poor understanding of safety recommendations for indwelling neuromodulatory devices, scoring only 39% on a pretest, but their knowledge significantly improved to 71% after educational interventions.

The implementation of an educational compendium in the operating room led to a 2.4 times decrease in case start times for vagus nerve stimulator procedures, demonstrating the effectiveness of improved training and resources in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Improvement Project: Improving Caregivers' Understanding of Safety Recommendations for Neurosurgical Devices. Anokwute, MC., Seibold, D., Jea, A., et al.[2022]

The study developed a test platform to assess electromagnetic interference (EMI) from low frequency RFID technology on implantable neurostimulators, which are commonly used for pain relief.

Results showed that the electric currents induced by low frequency RFID emitters did not significantly affect the electrical stimulation of the neurostimulator, suggesting that EMI from such sources may not pose a serious risk to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of induced electrical currents from magnetic field coupling inside implantable neurostimulator leads. Pantchenko, OS., Seidman, SJ., Guag, JW.[2021]

In a study involving 86 women with fibromyalgia, the combination of Low-Dose Naltrexone (LDN) and transcranial Direct Current Stimulation (tDCS) significantly reduced pain frequency and intensity, suggesting a potential synergistic effect for pain management.

While the LDN+tDCS group showed notable improvements in pain and depressive symptoms, a placebo effect was also observed, indicating the need for further research to clarify the true efficacy of this combined treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of low-dose naltrexone and transcranial direct current stimulation in fibromyalgia: a randomized, double-blinded, parallel clinical trial. Paula, TMH., Castro, MS., Medeiros, LF., et al.[2023]

Fibromyalgia is primarily characterized by chronic pain that often does not respond to traditional painkillers, suggesting a need for new treatment strategies.

Recent developments in pharmacological approaches focus on drugs that modulate the nociceptive system, either by enhancing the activity of pain-inhibiting amines or by reducing the excitability of pain pathways, showing promise in providing relief for fibromyalgia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacologic treatment of fibromyalgia: Towards chemical neuromodulation]. Collado, A., Conesa, A.[2012]

Citations

1. trials.arthritis.org trials.arthritis.org/trials/NCT06271746

Treatment of Fibromyalgia With the FibroNova ... The current study examines the safety and efficacy of REN technology, implemented via the FibroNova device for treating fibromyalgia pain and related symptoms.

2. app.trialscreen.org app.trialscreen.org/trials/treatment-fibromyalgia-fibronova-neuromodulation-device-trial-nct06271746

Treatment of Fibromyalgia With the FibroNova ... This study aims to investigate the safety and efficacy of the FibroNova device, which uses Remote Electrical Neuromodulation (REN) technology, in managing ...

3. withpower.com withpower.com/trial/phase-fibromyalgia-2-2024-0756d

Neuromodulation Device for Fibromyalgia Research on similar neuromodulation treatments, like the REAC technology, shows significant improvements in pain and quality of life for fibromyalgia patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0163834324000252/pdf

Efficacy of neuromodulation on the treatment of fibromyalgia In our opinion, the four common outcomes (pain, depression, anxiety and functioning) in fibromyalgia studies can be separated and analyzed using network meta- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11908403/

Evolution of the Quality of Life of Long-Term Fibromyalgia ... This study aimed to report real-world data on the long-term use (18 months) of a millimeter (MMW)-based neuromodulation device and tracking application.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06539793

Effect of Neuromodulation on Pain Biomarkers and ... Also called a data safety and monitoring ... Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome.