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NCT06271746
Treatment of Fibromyalgia With the FibroNova Neuromodulation Device
NA trial testing FibroNova (Active mode) in Fibromyalgia in 170 participants. Status unknown.
1 March 2025
Quick facts
| Lead sponsor | Theranica |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 4 March 2024 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 4 locations across United States, Israel |
Drugs / interventions tested
- FibroNova (Active mode)
- FibroNova (Sham mode)
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
Sponsor
Theranica — full company profile →
Who can join
Adults 18 to 70, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06271746
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other Theranica trials
Trials by the same sponsor.
- NCT05523310 — Observational Study to Assess Migraine Prediction Tool · suspended
- NCT07487701 — Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study · NA · active not recruiting
- NCT07336420 — Treatment Patterns Among US Veterans Using Remote Electrical Neuromodulation (REN) for Migraine Treatment · Phase 4 · completed
- NCT07336056 — Nerivio Efficacy Under High-Frequency Use · Phase 4 · active not recruiting
- NCT06976723 — Nerivio Efficacy by Time of Treatment Onset · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06271746 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Theranica
- Last refreshed: 11 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06271746.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing