RECRUITING

Treatment of Fibromyalgia With the FibroNova Neuromodulation Device

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Randomized, Double-blind, Sham-controlled Clinical Study Assessing the Safety and Efficacy of FibroNova for the Treatment of Fibromyalgia.

Quick Facts

Study Start:2024-03-04
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06271746

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient age is 18-70.
  2. 2. Meets ACR 2010 Diagnostic Criteria for FM.
  3. 3. Naïve to Nerivio and to FibroNova devices.
  4. 4. Possesses the basic cognitive and motor skills needed to operate his/her own smartphone.
  5. 5. Must be able and willing to comply with the protocol.
  6. 6. Must be able and willing to provide written informed consent.
  1. 1. Change in prescribed medications for pain and/or fibromyalgia in the two months prior to enrolment.
  2. 2. Pregnant or lactating.
  3. 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. 4. Newly diagnosed with fibromyalgia (under six months).
  5. 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. 6. Known uncontrolled epilepsy.
  7. 7. Active substance use disorder that could interfere with study participation.
  8. 8. Use of opioids during the 2 months prior to enrolment.
  9. 9. Has undergone nerve block (occipital or other) during the 2 months prior to enrolment.
  10. 10. Patients with severe depression, and/or suicidality
  11. 11. Is participating in any other clinical study.
  12. 12. Use of a neuromodulation device specifically indicated for FM ( e.g.Quell ) currently or in the 2 months prior to enrolment.

Contacts and Locations

Study Contact

Dagan Harris
CONTACT
+97272 3909752
daganh@theranica.com
Liron Rabani
CONTACT
+97272 3909752
Lironr@theranica.com

Principal Investigator

Daniel Clauw, MD
STUDY_CHAIR
University of Michigan

Study Locations (Sites)

Clinical Research Professionals
Chesterfield, Missouri, 63005
United States
ClinVest Headlands Research
Springfield, Missouri, 65807
United States
Gershon Pain Specialists
Virginia Beach, Virginia, 23454
United States

Collaborators and Investigators

Sponsor: Theranica

  • Daniel Clauw, MD, STUDY_CHAIR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-04
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2024-03-04
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • fibromyalgia
  • Neuromodulation

Additional Relevant MeSH Terms

  • Fibromyalgia