FibromyalgiaNCT06271746
Treatment of Fibromyalgia With the FibroNova Neuromodulation Device
A study testing FibroNova (Active mode) in people with Fibromyalgia, run by Theranica at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- FibroNova (Active mode)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 4 Mar 2024to 1 Jun 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age is 18-70.
- Meets ACR 2010 Diagnostic Criteria for FM.
- Naïve to Nerivio and to FibroNova devices.
- Possesses the basic cognitive and motor skills needed to operate his/her own smartphone.
- Must be able and willing to comply with the protocol.
- Must be able and willing to provide written informed consent.
Who cannot join
- Change in prescribed medications for pain and/or fibromyalgia in the two months prior to enrolment.
- Pregnant or lactating.
- 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).
- Newly diagnosed with fibromyalgia (under six months).
- 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).
- Known uncontrolled epilepsy.
Show all 12Show fewer
- Active substance use disorder that could interfere with study participation.
- Use of opioids during the 2 months prior to enrolment.
- Has undergone nerve block (occipital or other) during the 2 months prior to enrolment.
- Patients with severe depression, and/or suicidality
- Is participating in any other clinical study.
- Use of a neuromodulation device specifically indicated for FM ( e.g.Quell ) currently or in the 2 months prior to enrolment.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Clinical Research Professionals
Chesterfield, Missouri, 63005
Shahmir Kahn, 636-220-1200, skhan@clinicalresearchprofessionals.net
Daniel Mattson, MD
- Recruiting
ClinVest Headlands Research
Springfield, Missouri, 65807
Brittni kendrick, 417-883-7889, brittni.kendrick@clinvest.com
David True, MD
- Recruiting
Gershon Pain Specialists
Virginia Beach, Virginia, 23454
Erika Dorman, 757-496-2050, edorrman@gershonpain.com
Steven Gershon, MD
Israel1 site, 1 recruiting
- Not yet recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Sara Pel, +972-52-4266605, sarap@tlvmc.gov.ii
Ori Elkayam, MD
About this study
Official title: A Prospective, Randomized, Double-blind, Sham-controlled Clinical Study Assessing the Safety and Efficacy of FibroNova for the Treatment of Fibromyalgia.
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.
Read more
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- FibroNova (Active mode), FibroNova (Sham mode)
- Keywords
- fibromyalgia, Neuromodulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroNova (Active mode)Device
FibroNova neurostimulator of conditional pain modulation (CPM)
FibroNova (Sham mode)Device
FibroNova neurostimulator with an electrical output not intended for neurostimulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment with active FibroNova device | Active comparator | Treatment of Fibromyalgia pain and symptoms with active FibroNova device. Participants will treat with an active device twice a day. Receives: Device: FibroNova (Active mode) |
| Treatment with Sham FibroNova device | Placebo comparator | Treatment of Fibromyalgia pain and symptoms with Sham FibroNova device. Participants will treat with a sham device twice a day. Receives: Device: FibroNova (Sham mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Mean change, from the last two weeks (weeks 3-4) of the baseline phase to the last two weeks (weeks 15-16) of the intervention phase, in the 2-week average of daily self-reported pain severity scores on NRS (0 to 10) that is based on the FIQR pain item.
Measured: 16 weeks
Device safety (rate of adverse events and device related adverse events)
The incidence of adverse events in general and by seriousness, severity and association to the device.
Measured: 28 weeks
Secondary outcomes (6)
Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score
Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score from the end of the baseline phase (end of week 4) to the end of the intervention.phase (end of week 16)
Measured: 16 weeks
Mean change in FIQR functionality sub-scale score
Mean change in FIQR functionality sub-scale score from the end of the baseline phase (end of week 4) to the end of the intervention.phase (end of week 16)
Measured: 16 weeks
Mean change in FIQR pain item score
Mean change in FIQR pain item score from the end of the baseline phase (end of week 4) to the end of the intervention.phase (end of week 16)
Measured: 16 weeks
Mean change in Brief Pain Inventory (BPI) score
Mean change in Brief Pain Inventory (BPI) from the end of the baseline phase (end of week 4) to the end of the intervention.phase (end of week 16)
Measured: 16 weeks
Improvement in patient global impression according to PGIC score
Percentage of participants who were categorized as "Improved (Very Much Improved, Much Improved, or Minimally Improved)" According to the Patient Global Impressions of Change (PGIC) at the end of week 12.
Measured: 16 weeks
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)
Mean change, from the last two weeks of the baseline phase (weeks 3-4 to the last two weeks of the intervention phase (weeks 15-16), in the 2-week average of daily self-reported functional disability scores on NRS (0 to 10) that is based on the FIQR disability item.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start4 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Parallel Assignment. Randomized, double-blind, sham-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Clauw, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271746
- Sponsor's protocol ID
- TCH101
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Sham-controlled Clinical Study Assessing the Safety and Efficacy of FibroNova for the Treatment of Fibromyalgia.
- ClinicalTrials.gov ID
- NCT06271746
- Acronym / sponsor ID
- TCH101
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 22 Feb 2024 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment. Randomized, double-blind, sham-controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment with active FibroNova device | Active comparator | Device: FibroNova (Active mode)Treatment of Fibromyalgia pain and symptoms with active FibroNova device. Participants will treat with an active device twice a day. |
| Treatment with Sham FibroNova device | Placebo comparator | Device: FibroNova (Sham mode)Treatment of Fibromyalgia pain and symptoms with Sham FibroNova device. Participants will treat with a sham device twice a day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient age is 18-70.
- Meets ACR 2010 Diagnostic Criteria for FM.
- Naïve to Nerivio and to FibroNova devices.
- Possesses the basic cognitive and motor skills needed to operate his/her own smartphone.
- Must be able and willing to comply with the protocol.
Key exclusion criteria (12 listed)
- Change in prescribed medications for pain and/or fibromyalgia in the two months prior to enrolment.
- Pregnant or lactating.
- 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).
- Newly diagnosed with fibromyalgia (under six months).
- 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).
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 |
|---|---|---|
| FibroNova (Active mode)FibroNova neurostimulator of conditional pain modulation (CPM) | Device | Treatment with active FibroNova device |
| FibroNova (Sham mode)FibroNova neurostimulator with an electrical output not intended for neurostimulation | Device | Treatment with Sham FibroNova device |
Primary outcome
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)
Time frame: 16 weeks
Mean change, from the last two weeks (weeks 3-4) of the baseline phase to the last two weeks (weeks 15-16) of the intervention phase, in the 2-week average of daily self-reported pain severity scores on NRS (0 to 10) that is based on the FIQR pain item.
Device safety (rate of adverse events and device related adverse events)
Time frame: 28 weeks
The incidence of adverse events in general and by seriousness, severity and association to the device.
6 secondary outcomes
Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score
Time frame: 16 weeks
Mean change in FIQR functionality sub-scale score
Time frame: 16 weeks
Mean change in FIQR pain item score
Time frame: 16 weeks
Mean change in Brief Pain Inventory (BPI) score
Time frame: 16 weeks
Improvement in patient global impression according to PGIC score
Time frame: 16 weeks
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)
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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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 Clauw, MD study chair
University of Michigan
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroNova (Active mode) in people with Fibromyalgia, run by Theranica at 4 sites in 2 countries.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dagan Harris (+97272 3909752, daganh@theranica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 11 Apr 2024.